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U.S. Department of Health and Human Services

Class 2 Device Recall Various Names

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  Class 2 Device Recall Various Names see related information
Date Initiated by Firm August 24, 2023
Date Posted September 25, 2023
Recall Status1 Open3, Classified
Recall Number Z-2634-2023
Recall Event ID 92933
Product Classification unknown device name - Product Code N/A
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.
Code Information Various
Recalling Firm/
Manufacturer		 Inmar Supply Chain Solutions, LLC
1131 W Bardin Rd Ste 131
Arlington TX 76017-6082
For Additional Information Contact Chris Yerzey
209-480-3281
Manufacturer 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.
FDA Determined
Cause 2		 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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