Z-1517-2022Class II

(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No...

Name: Z-1517-2022 (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No...
Creator: Aso Llc
Published: 2022-06-22
License: https://open.fda.gov/license/

Aso LLC / initiated 2022-06-22 / Open, Classified / root cause: manufacturing process

FDA source

ASO LLC began a recall of (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... on 2022-06-22. FDA classified it as Class II and gives the reason as "The product falls apart during handling after removal from its primary packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1517-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-22
Posted: 2022-08-12
Recalling firm: Aso LLC
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.
Product code: FQM Bandage, Elastic
Reason for recall: The product falls apart during handling after removal from its primary packaging.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1517-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1517-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-24	2022-08-12

Product code FQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)