First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Scie...

FDA Device Recall #Z-1031-2022 — Class II — March 2, 2022

Recall Summary

Recall Number Z-1031-2022
Classification Class II — Moderate risk
Date Initiated March 2, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ASO LLC
Location Sarasota, FL
Product Type Devices
Quantity 73,668 kits

Product Description

First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)

Reason for Recall

Kits contained recalled acetaminophen.

Distribution Pattern

US Nationwide distribution.

Lot / Code Information

Product distributed in first kits under the following names/codes: 1) Equate (Walmart) - FIRST AID KIT 140 PIECES, SKU #s 566904301 and 567925067 - contains acetaminophen with Pouch lot #6132 (expired 09/2021). Kit was sold under ASO Item Nos: a) 187619: Lots 00106279 (EXP 4/1/2021); 00106525 (EXP 6/1/2020); 00106615 (EXP 3/1/2021); 00108538 (EXP 3/1/2021); 19252 (EXP.9/1/2021); and 19253 (EXP.9/1/2021) b) 188583: Lots 00106926 (EXP 6/1/2020); 00107119 (EXP 3/1/2021); 00108453 (EXP 3/1/2021); 00106615 (EXP 3/1/2021), and 00108538 (EXP 3/1/2021). 2) Meijer - FIRST AID KIT 150 PIECES, SKU #4212608-024-002 - contains acetaminophen with Pouch lot #6132 (expired 09/2021). Kit was sold under ASO Item No. 189099, Lot #00107831 (EXP 10/01/2020) 3) Care Science (Amazon) - FIRST AID KIT 200 PIECES, SKU #B07CQBNWQY - contains acetaminophen with Pouch lot #6132 (expired 09/2021). Kit was sold under ASO Item No. #188819, Lot #00112542 (EXP 06/01/2021).

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-1517-2022 Class II (1) CVS Health Sterile Surgical Pads, Cushion C... Jun 22, 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.