FDA · Medical device recall

Alpha Conducting solution product codes:3310-15 ACS… and 4 more products

July 24, 2019 Class II

Date: July 24, 2019
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: Pharmaceutical Innovations, Inc.
Reason: Potential for failed stability antimicrobial effectiveness testing.
Distribution pattern: US nationwide distribution including the states of AZ, CA, CT, FL, IL, MA, MI, MN, NC, NJ, NY, OH, PA, RI, TX, TN, VT, WV. Distributed Internationally to accounts in Australia, France, Germany, Hong Kong, Saudi Arabia and Canada.

5 products in this recall

Alpha Conducting solution product codes:3310-15 ACS…

Product: Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution.
Quantity: 87140
Codes and lots: Lot # 081914-15, 111715-15, 070116-15, 020117-15, 080117-15, 010118-15, 041618-15, 041618A-15, 071618-15, 102018-15
Recall started: June 19, 2019
Device type: Media, Electroconductive
Root cause (FDA): Other
What the company told customers: On June 21,2019, Pharmaceutical Innovations issued Urgent Medical Device notices to customers via email. Customers were instructed to do the following: 1) Examine inventory, Isolate and quarantine these products. 2) Notify any end users, customers or additional facilities within your organization to discontinue use and sale and quarantine those products until final disposition has been determined and performed. 3) Return the MEDICAL DEVICE RECALL RETURN RESPONSE form to James Hurlman at Pharmaceutical Innovations, Inc, email : jimh@pharminnovations.com, Fax:973-242-0578. 4) Pharmaceutical Innovations, Inc. will send you a confirmation of receipt of the Recall Return Response Form for your records. 5) An RMA (Return Material Authorization) or LOD (Letter of Destruction) will be issued as requested by you in the Recall Return Response Form. The RMA will have instructions on how to return the product. 6) All LOD requests must be accompanied by photographs of actual product to receive credit and or reimbursement. Customers with questions may contact the firm Monday through Friday, 8:30 AM to 3:30 PM, Eastern Time. Phone: 973-242-2900 Fax:973-242-0578 Email: jimh@pharminnovations.com
Recall number: Z-1968-2019

ElectroMist product codes: 36-3310-25…

Product: ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
Quantity: 71653
Codes and lots: Lot # 060714-25, 080614-25, 101515-25, 070116-25, 072816-25A, 072816-25, 021317-25, 010118-25,102018-25.
Recall started: June 19, 2019
Device type: Media, Electroconductive
Root cause (FDA): Other
What the company told customers: On June 21,2019, Pharmaceutical Innovations issued Urgent Medical Device notices to customers via email. Customers were instructed to do the following: 1) Examine inventory, Isolate and quarantine these products. 2) Notify any end users, customers or additional facilities within your organization to discontinue use and sale and quarantine those products until final disposition has been determined and performed. 3) Return the MEDICAL DEVICE RECALL RETURN RESPONSE form to James Hurlman at Pharmaceutical Innovations, Inc, email : jimh@pharminnovations.com, Fax:973-242-0578. 4) Pharmaceutical Innovations, Inc. will send you a confirmation of receipt of the Recall Return Response Form for your records. 5) An RMA (Return Material Authorization) or LOD (Letter of Destruction) will be issued as requested by you in the Recall Return Response Form. The RMA will have instructions on how to return the product. 6) All LOD requests must be accompanied by photographs of actual product to receive credit and or reimbursement. Customers with questions may contact the firm Monday through Friday, 8:30 AM to 3:30 PM, Eastern Time. Phone: 973-242-2900 Fax:973-242-0578 Email: jimh@pharminnovations.com
Recall number: Z-1969-2019

ElectroMist product codes: 36-3310-60…

Product: ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
Quantity: 8982
Codes and lots: Lot # 051914-60, 101615-60, 021317-60
Recall started: June 19, 2019
Device type: Media, Electroconductive
Root cause (FDA): Other
What the company told customers: On June 21,2019, Pharmaceutical Innovations issued Urgent Medical Device notices to customers via email. Customers were instructed to do the following: 1) Examine inventory, Isolate and quarantine these products. 2) Notify any end users, customers or additional facilities within your organization to discontinue use and sale and quarantine those products until final disposition has been determined and performed. 3) Return the MEDICAL DEVICE RECALL RETURN RESPONSE form to James Hurlman at Pharmaceutical Innovations, Inc, email : jimh@pharminnovations.com, Fax:973-242-0578. 4) Pharmaceutical Innovations, Inc. will send you a confirmation of receipt of the Recall Return Response Form for your records. 5) An RMA (Return Material Authorization) or LOD (Letter of Destruction) will be issued as requested by you in the Recall Return Response Form. The RMA will have instructions on how to return the product. 6) All LOD requests must be accompanied by photographs of actual product to receive credit and or reimbursement. Customers with questions may contact the firm Monday through Friday, 8:30 AM to 3:30 PM, Eastern Time. Phone: 973-242-2900 Fax:973-242-0578 Email: jimh@pharminnovations.com
Recall number: Z-1970-2019

ElectroMist product codes: 36-3310-04…

Product: ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.
Quantity: 630
Codes and lots: Lot # 030215-04, 011716-04, 072816-04, 072816-04, 071618-04, 080117-04
Recall started: June 19, 2019
Device type: Media, Electroconductive
Root cause (FDA): Other
What the company told customers: On June 21,2019, Pharmaceutical Innovations issued Urgent Medical Device notices to customers via email. Customers were instructed to do the following: 1) Examine inventory, Isolate and quarantine these products. 2) Notify any end users, customers or additional facilities within your organization to discontinue use and sale and quarantine those products until final disposition has been determined and performed. 3) Return the MEDICAL DEVICE RECALL RETURN RESPONSE form to James Hurlman at Pharmaceutical Innovations, Inc, email : jimh@pharminnovations.com, Fax:973-242-0578. 4) Pharmaceutical Innovations, Inc. will send you a confirmation of receipt of the Recall Return Response Form for your records. 5) An RMA (Return Material Authorization) or LOD (Letter of Destruction) will be issued as requested by you in the Recall Return Response Form. The RMA will have instructions on how to return the product. 6) All LOD requests must be accompanied by photographs of actual product to receive credit and or reimbursement. Customers with questions may contact the firm Monday through Friday, 8:30 AM to 3:30 PM, Eastern Time. Phone: 973-242-2900 Fax:973-242-0578 Email: jimh@pharminnovations.com
Recall number: Z-1971-2019

Alpha Conducting solution product codes: 3310-25 ASCR…

Product: Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.
Quantity: N/A
Codes and lots: Lot # 032014-25, 060515-25,101615-25, 011716-25, 021317-25, 080117-25, 010118A-25, 041618-25, 071618-25, 102018A-25
Recall started: June 19, 2019
Device type: Media, Electroconductive
Root cause (FDA): Other
What the company told customers: On June 21,2019, Pharmaceutical Innovations issued Urgent Medical Device notices to customers via email. Customers were instructed to do the following: 1) Examine inventory, Isolate and quarantine these products. 2) Notify any end users, customers or additional facilities within your organization to discontinue use and sale and quarantine those products until final disposition has been determined and performed. 3) Return the MEDICAL DEVICE RECALL RETURN RESPONSE form to James Hurlman at Pharmaceutical Innovations, Inc, email : jimh@pharminnovations.com, Fax:973-242-0578. 4) Pharmaceutical Innovations, Inc. will send you a confirmation of receipt of the Recall Return Response Form for your records. 5) An RMA (Return Material Authorization) or LOD (Letter of Destruction) will be issued as requested by you in the Recall Return Response Form. The RMA will have instructions on how to return the product. 6) All LOD requests must be accompanied by photographs of actual product to receive credit and or reimbursement. Customers with questions may contact the firm Monday through Friday, 8:30 AM to 3:30 PM, Eastern Time. Phone: 973-242-2900 Fax:973-242-0578 Email: jimh@pharminnovations.com
Recall number: Z-1972-2019

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1968-2019, Z-1969-2019, Z-1970-2019, Z-1971-2019, Z-1972-2019. The agency record governs; check it and the company before acting.

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