Amerx Recalls Amerigel Daily Dressing for Unapproved Labeling Claims
Amerx Health Care Corp. is recalling Amerigel Daily Dressing Advanced 3-in-1 Hydrogel because the product labeling includes unapproved claims for antimicrobial and autolytic debridement.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to unapproved labeling claims, which fits the rubric for moderate severity involving minor labeling errors or voluntary precautionary recalls without reported injuries.
Plain-English summary
Amerx Health Care Corp. is voluntarily recalling approximately 1,740 units of Amerigel Daily Dressing Advanced 3-in-1 Hydrogel, catalog number A2003. The product consists of 30 single-use foil packets, each containing 1g of hydrogel, and is used for wound management. The recall is limited to lot code 2WD07.
The recall was initiated because the product labeling contains claims that the dressing is antimicrobial and provides autolytic debridement. The U.S. Food and Drug Administration has not approved these specific labeling claims for this device. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected product was distributed nationwide in the United States, including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, as well as in Canada, England, Africa, and Australia. Consumers and healthcare providers who have this specific lot of the product should stop using it and contact Amerx Health Care Corp. for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
- Manufacturer
- Amerx Health Care Corp.
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 1,740
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot codes: 2WD07.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Amerx Health Care Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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