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U.S. Department of Health and Human Services

Class 2 Device Recall CVS Health

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  Class 2 Device Recall CVS Health see related information
Date Initiated by Firm June 22, 2022
Create Date August 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-1517-2022
Recall Event ID 90538
Product Classification Bandage, elastic - Product Code FQM
Product (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111

(2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and

(3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.
Code Information Item 781083: Lot numbers 2384-20201116, 2384-20201123, 2384-20201212, 2384-20201226, 2384-20210111, 2384-20210120, 2384-20210306, 2384-20210327, 2384-20210329, 2384-20210411, 2384-20210522, 2384-20210528, 2384-20210604, 2384-20210610, 2384-20210615, 2384-20210619; UPC 050428310229, UDI: 050428310229. Item 781240: Lot numbers 2384-20201109, 2384-20201214, 2384-20201220, 2384-20201223, 2384-20210117, 2384-20210127, 2384-20210320, 2384-20210501, 2384-20210502, 2384-20210508, 2384-20210523, 2384-20210703, 2384-20210904, 2384-20210910; UPC 5042899705, UDI: 050428297056 Item 192636: equate First Aid Kit lot #00163199, generic sterile trauma pad lot #2384-20210829, UPC: 627735013176, UDI: N/A.
Recalling Firm/
Manufacturer		 ASO LLC
300 Sarasota Center Blvd
Sarasota FL 34240-9381
For Additional Information Contact Complaints
855-823-4545
Manufacturer Reason
for Recall		 The product falls apart during handling after removal from its primary packaging.
FDA Determined
Cause 2		 Process control
Action The recalling firm initiated the recall via email on 6/22/2022 to return the product.
Quantity in Commerce 274,458 retail packages
Distribution Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI SC, TN, TX, and VA. The country of Canada.
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.
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