SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
FDA Device Recall #Z-0004-2014 — Class II — August 21, 2013
Recall Summary
| Recall Number | Z-0004-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 21, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ASO, LLC |
| Location | Sarasota, FL |
| Product Type | Devices |
| Quantity | 37 cases (72 retail boxes in each case) |
Product Description
SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
Reason for Recall
No antibacterial bandages were packed in boxes labeled as antibacterial.
Distribution Pattern
Distributed in the states of ID, WI, IN, and NE.
Lot / Code Information
UPC Code #: 400129133311 Lot numbers: 330543 and 341383
Other Recalls from ASO, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0525-2019 | Class II | Family Wellness First Aid Sterile Gauze Pad 3... | Oct 16, 2018 |
| Z-2460-2015 | Class II | Carepak Sheer Adhesive Bandages 50 Sterile Band... | Jun 10, 2015 |
| Z-1894-2013 | Class II | Premier Value Wound Closure Adhesive Surgical T... | Jul 26, 2013 |
| Z-1888-2013 | Class II | CVS Pharmacy Wound Closure Adhesive Surgical Ta... | Jul 26, 2013 |
| Z-1891-2013 | Class II | HEB Wound Closure Adhesive Surgical Tape Strips... | Jul 26, 2013 |
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.