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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Amerx Health Care Corp.: Not approved labeling claims (antimicrobial and autolytic debridement)

Agency Publication Date: September 12, 2014
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Affected Products

Product: Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.

Lot codes: 3WD02, 3WD03, 3WD04, and 3WD05

Lot Numbers:
codes
Product: Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.

Lot codes: 05368, 05345, 09282, 10295, 12201, 12303, 12303, 12328, 13100, 13115, and 13180.

Lot Numbers:
codes
Product: Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.

Lot codes: JCA0086 through JCA0106.

Lot Numbers:
codes
Product: Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.

Lot codes: 2WD07.

Lot Numbers:
codes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 69083
Status: Resolved
Manufacturer: Amerx Health Care Corp.
Manufactured In: United States
Units Affected: 4 products (382,620 units; 21,108 units; 116,633 units; 1,740 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.