(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, AS...
FDA Device Recall #Z-1517-2022 — Class II — June 22, 2022
Recall Summary
| Recall Number | Z-1517-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 22, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ASO LLC |
| Location | Sarasota, FL |
| Product Type | Devices |
| Quantity | 274,458 retail packages |
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.
Reason for Recall
The product falls apart during handling after removal from its primary packaging.
Distribution Pattern
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.
Lot / 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.
Other Recalls from ASO LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1499-2023 | Class II | WALGREENS BANDAGES, item number 196568, 110 CT ... | Mar 23, 2023 |
| Z-1031-2022 | Class II | First Aid Kits containing acetaminophen under b... | Mar 2, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.