Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2634-2023Class II

Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood...

Inmar Supply Chain Solutions, LLC / initiated 2023-08-24 / Open, Classified / root cause: labeling and UDI

Inmar Supply Chain Solutions, LLC began a recall of Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monitors, adult diapers, COVID-19 test kits... on . FDA classified it as Class II and gives the reason as "Various medical devices potentially exposed to rodent and rodent activity. In addition, medical devices may have been subjected to temperatures in excess of storage requirements on product labeling". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2634-2023
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Inmar Supply Chain Solutions, LLC
Product
Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monitors, adult diapers, COVID-19 test kits, and pregnancy tests.
Product code
N/A
Reason for recall
Various medical devices potentially exposed to rodent and rodent activity. In addition, medical devices may have been subjected to temperatures in excess of storage requirements on product labeling.
Root cause tag
labeling and UDI
FDA root cause
Unknown/Undetermined by firm
Action
Beginning on August 15, 2023, Inmar Supply Chain Solutions, LLC notified consignees via email and company website concerning a voluntary recall. On August 23, 2023, Inmar issued a press release concerning the matter. The recall instructions are for the products to be destroyed by the liquidation buyer.
Quantity in commerce
unknown
Distribution
US Nationwide distribution.
Product codes and lots
Various

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2634-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2634-2023Class IIOngoingVoluntary: Firm initiated