PlainRecordsMEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER… and 2 more products
- Reason
- Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process.
- Status
- Ongoing
- Distribution
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico. International…
- Enforcement report date
- Oct. 5, 2022
- 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
- Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- MEDLINE INDUSTRIES, LP - Northfield
- Reason
- Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process.
- Distribution pattern
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico. International distribution to Canada, Chile, Colombia, Panama, Qatar, United Arab Emirates
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process.”MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. ET LENGTH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12; b. ET LENGTH DOUBLE SWIVEL, 14 Fr, Item Number/REF: DYNCPDS14; c. ET LENGTH DOUBLE SWIVEL, 16 Fr, Item Number/REF: DYNCPDS16, FDA enforcement report, 2022-10-05. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Catheters, Suction, Tracheobronchial
Distributed in (FDA's record): Alabama Alaska Arizona Arkansas California Colorado Connecticut District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming and nationwide
3 products in this recall
MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER…
- Product
- MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. ET LENGTH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12; b. ET LENGTH DOUBLE SWIVEL, 14 Fr, Item Number/REF: DYNCPDS14; c. ET LENGTH DOUBLE SWIVEL, 16 Fr, Item Number/REF: DYNCPDS16
- Quantity
- 65,320 units
- Codes and lots
- a. UDI-DI (GTIN) case: (01)20888277703367; UDI-DI (GTIN) Each: (01)10888277703360, Lot Number 6922040021; b. UDI-DI (GTIN) case: (01)20888277703381; UDI-DI (GTIN) Each: (01)10888277703384, Lot Numbers 6921050011, 6921070011, 6921070021, 6921060011, 6921060021, 6921080011, 6921100011, 6921100021, 6921120011, 6922010011, 6922020021, 6922030011; c. UDI-DI (GTIN) case: (01)20888277703404; UDI-DI (GTIN) Each: (01)10888277703407, Lot Number 6921120021
- Recall started
- Aug. 3, 2022
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Catheters, Suction, Tracheobronchial
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- On about 08/03/2022, Medline notified consignees via first class mail letter of the recall. The letter instructed consignees to immediately review inventory and destroy all affected product and complete the response form indicated at the link provided in the letter. Distributors were instructed to notify customers if further distributed, instruct those customers destroy any affected product, and include customer quantities on response form.
- Recall number
- Z-1855-2022
MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER…
- Product
- MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12T b. TRACH DOUBLE SWIVEL, 14 Fr, Item Number/REF: DYNCPDS14T
- Quantity
- 34,920 units
- Codes and lots
- a. UDI-DI (GTIN) case: (01)20888277703374; UDI-DI (GTIN) Each: (01)10888277703377, Lot Numbers 6921090011, 6922030011; b. UDI-DI (GTIN) case: (01)20888277703398; UDI-DI (GTIN) Each: (01)10888277703391, Lot Numbers 6921040012, 6921070011, 6921080011, 6921100011, 6921120011, 6921120021, 6922030011, 6922040011
- Recall started
- Aug. 3, 2022
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Catheters, Suction, Tracheobronchial
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- On about 08/03/2022, Medline notified consignees via first class mail letter of the recall. The letter instructed consignees to immediately review inventory and destroy all affected product and complete the response form indicated at the link provided in the letter. Distributors were instructed to notify customers if further distributed, instruct those customers destroy any affected product, and include customer quantities on response form.
- Recall number
- Z-1856-2022
MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER…
- Product
- MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14; b. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14T
- Quantity
- 136,080 units
- Codes and lots
- a. UDI-DI (GTIN) case: (01)20888277703466; UDI-DI (GTIN) Each: (01)10888277703469, Lot Numbers 6922030011; b. UDI-DI (GTIN) case: (01)20888277703473; UDI-DI (GTIN) Each: (01)10888277703476, Lot Numbers 6921050011, 6921060011, 6921040012, 6921110011, 6921120011 6921120012, 6922010011, 6922010012, 6922010031, 6922020031, 6922030011.
- Recall started
- Aug. 3, 2022
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Catheters, Suction, Tracheobronchial
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- On about 08/03/2022, Medline notified consignees via first class mail letter of the recall. The letter instructed consignees to immediately review inventory and destroy all affected product and complete the response form indicated at the link provided in the letter. Distributors were instructed to notify customers if further distributed, instruct those customers destroy any affected product, and include customer quantities on response form.
- Recall number
- Z-1857-2022
This recall among the others
- FDA's enforcement report came 63 days after the firm started the recall. For half of the 888 FDA medical device recall events reported in 2022 with a start date, it took 54 days or fewer (by year).
- MEDLINE INDUSTRIES: 46 other recalls or notices on this site in the three years before this one (from Oct. 6, 2019).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-1855-2022, Z-1856-2022, Z-1857-2022. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1855-2022, Oct. 5, 2022. "MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER… and 2 more products." PlainRecords, https://plainrecords.com/recall/device/z-1855-2022/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections