Amerx Recalls Amerigel Hydrogel Gauze Dressing for Nonapproved Sterile Labeling
Amerx Health Care Corp. is recalling Amerigel Hydrogel Gauze Dressing 2 x 2 due to nonapproved labeling claims regarding sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 and involves a labeling error (nonapproved sterile claims) without reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Amerx Health Care Corp. is recalling 6,491 units of Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. The recall is being conducted because the product bears nonapproved labeling claims stating it is sterile.
The affected lots are 11406, 11414, 12439, 12466, and 02521. The product was distributed worldwide, including the United States, Canada, and Bahrain.
Consumers and healthcare providers should stop using the affected product and contact Amerx Health Care Corp. for instructions on return or replacement.
The recalled product
- Product
- Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
- Manufacturer
- Amerx Health Care Corp.
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 6,491
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 (5)
- ALL Lots - 11406
- 11414
- 12439
- 12466
- and 02521.
Distribution
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