Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x...
FDA Device Recall #Z-2640-2014 — Class II — July 11, 2014
Recall Summary
| Recall Number | Z-2640-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 11, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Amerx Health Care Corp. |
| Location | Clearwater, FL |
| Product Type | Devices |
| Quantity | 116,633 units |
Product Description
Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.
Reason for Recall
Not approved labeling claims (antimicrobial and autolytic debridement)
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.
Lot / Code Information
Lot codes: JCA0086 through JCA0106.
Other Recalls from Amerx Health Care Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2249-2016 | Class II | Amerigel Hydrogel Wound Dressing Advanced Formu... | May 20, 2016 |
| Z-1797-2015 | Class II | Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. ... | Feb 25, 2015 |
| Z-0500-2015 | Class II | Amerigel Saturated Gauze Dressing Wound mana... | Sep 26, 2014 |
| Z-0498-2015 | Class II | Amerigel Post-op Surgical Kits Wound management | Sep 26, 2014 |
| Z-0497-2015 | Class II | Amerigel Hydrogel Wound Dressing Wound manag... | Sep 26, 2014 |
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.