Class 2 Device Recall Various Names

• Date Initiated by Firm: August 24, 2023
• Date Posted: September 25, 2023
• Recall Status: Open, 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
• FEI Number: 3009127711
• 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: 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.