Class 2 Device Recall Walgreens

• Date Initiated by Firm: March 23, 2023
• Date Posted: May 02, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1499-2023
• Recall Event ID: 91970
• Product Classification: Tape and bandage, adhesive - Product Code KGX
• Product: WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES (retail package)
• Code Information: UDI/DI 311917124506; Lot Numbers: 00176259, 00176260, 00176582.
• FEI Number: 1038758
• Recalling Firm/ Manufacturer: ASO LLC; 300 Sarasota Center Blvd; Sarasota FL 34240-9381
• For Additional Information Contact: ASO Complaints; 855-823-4545 Ext. 1156
• Manufacturer Reason for Recall: The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.
• FDA Determined Cause: Process design
• Action: ASO sent an email to the headquarters of its sole consignee on 03/23/2023 to notify them of the intent to recall the product. The notice explained the issue and the risk and requested the return of the product from the retail level.
• Quantity in Commerce: 919 cases of 24 units
• Distribution: US Nationwide Distribution: IL. FL, CA, CT, OH, TX, IL, SC, and WI
• Total Product Life Cycle: TPLC Device Report

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.