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CVS Health recallZ-1517-2022 · Aso LLC · initiated Jun 22, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Aso LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The product falls apart during handling after removal from its primary packaging.

FDA root cause category: Process control

What the company is doing

The recalling firm initiated the recall via email on 6/22/2022 to return the product.

Recall details

Recall number
Z-1517-2022
Status
Open, Classified
Initiated by the company
Jun 22, 2022
Recalling firm
Aso LLC
Quantity
274,458 retail packages
Product code
FQM
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.

Product description

(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 (models, lots, serial numbers)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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