FDA · Medical device recall

Zoll REF: 8700-0782-01 (IC-3893)… and 27 more products

Oct. 13, 2021 Class II

Date: Oct. 13, 2021
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: ZOLL Circulation, Inc.
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, TAIWAN, THAILAND.

28 products in this recall

Zoll REF: 8700-0782-01 (IC-3893)…

Product: Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
Quantity: 17,869 Kits
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0039-2022

Zoll…

Product: Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3
Quantity: 1,253 Kits
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0040-2022

ZOLL…

Product: ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190
Quantity: 4,812 kits
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0041-2022

ZOLL…

Product: ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
Quantity: 5,524 Kits
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0042-2022

ZOLL…

Product: ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
Quantity: 5, 345 KIts
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0043-2022

ZOLL…

Product: ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510
Quantity: 11 UNITS
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0044-2022

ZOLL…

Product: ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213
Quantity: 6,395 units
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0045-2022

ZOLL…

Product: ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
Quantity: 333 units
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0046-2022

Zoll REF: 8700-0782-40 (IC-3893AE)…

Product: Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251
Quantity: 33,066 units
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0047-2022

Zoll REF: 8700-0783-01 (IC-4593)…

Product: Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282
Quantity: 20,475 units
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0048-2022

Zoll REF: 8700-0783-40 (IC-4593AE)…

Product: Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275
Quantity: 13,935 units
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0049-2022

Zoll REF: 8700-0782-14 (IC-3893CO)…

Product: Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527
Quantity: 1,256 units
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0050-2022

Zoll REF: 8700-0783-14 (IC-4593CO)…

Product: Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075534
Quantity: 188 units
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0051-2022

Zoll REF: 8700-0793-14 (SL-2593CO)…

Product: Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541
Quantity: 98 units
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0052-2022

Zoll…

Product: Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305
Quantity: 1,733 units
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0053-2022

Zoll…

Product: Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173
Quantity: 2,833 units
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0054-2022

Zoll…

Product: Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180
Quantity: 3,425 units
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0055-2022

Zoll…

Product: Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077
Quantity: 3 units
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0056-2022

Zoll…

Product: Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107
Quantity: 58 kits
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0057-2022

Zoll…

Product: Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)
Quantity: 16 bundles
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0058-2022

Zoll…

Product: Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
Quantity: 55 bundles
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0059-2022

Zoll…

Product: Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
Quantity: 42 bundles
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0060-2022

Zoll…

Product: Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
Quantity: 334 bundles
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0061-2022

Zoll…

Product: Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)
Quantity: 79 bundles
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0062-2022

Zoll…

Product: Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Quantity: 144 bundles
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0063-2022

Zoll…

Product: Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Quantity: 1,122 bundled kits
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0064-2022

Zoll…

Product: Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Quantity: 579 bundled kits
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0065-2022

Zoll…

Product: Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Quantity: 322 BUNDLE KITS
Codes and lots: All Lots
Recall started: Aug. 6, 2021
Device type: System, Hypothermia, Intravenous, Cooling
Root cause (FDA): Labeling design
What the company told customers: Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
Recall number: Z-0066-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0039-2022, Z-0040-2022, Z-0041-2022, Z-0042-2022, Z-0043-2022, Z-0044-2022, Z-0045-2022, Z-0046-2022 and others. The agency record governs; check it and the company before acting.

Report a mistake on this page