Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Walgreens

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Walgreens see related information
Date Initiated by Firm March 23, 2023
Date Posted May 02, 2023
Recall Status1 Open3, 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.
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 2		 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.
-
-