Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monit
Summary
The FDA issued a Class II for Various Medical Products stored on pallets, including but not limited to bandage by Inmar Supply Chain Solutions, LLC. Reason: Various medical devices potentially exposed to rodent and rodent activity. In addition, medical devices may have been subjected to temperatures in exc.
Details
Source
Device Recall
External ID
Z-2634-2023
Action Date
2023-10-04
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Various
Quantity Affected: unknown
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-24
Company
Arlington, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Inmar Supply Chain Solutions, LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Inmar Supply Chain Solutions, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Inmar Supply Chain Solutions, LLC have FDA actions?
Inmar Supply Chain Solutions, LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2634-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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