Amerx Recalls Amergel Hydrogel Gauze Dressing for Unapproved Labeling Claims
Amerx Health Care Corp. is recalling Amergel Hydrogel Saturated Gauze Dressing pads because the product labeling includes unapproved claims regarding antimicrobial and autolytic debridement properties.
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 but is driven by labeling errors (unapproved claims) rather than a physical defect or contamination, fitting the 'Minor labeling errors' criterion for a Moderate severity score.
Plain-English summary
Amerx Health Care Corp. is recalling 21,108 units of Amergel Hydrogel Saturated Gauze Dressing, specifically the 10 individually packaged pads size 2x2 4 Ply Pads (CAT # A5002). The recall is due to not approved labeling claims, specifically regarding antimicrobial and autolytic debridement.
The affected products were distributed worldwide, including nationwide in the United States (including the District of Columbia, Virgin Islands, Puerto Rico, and Guam) and in Canada, England, Africa, and Australia. The specific lot codes involved are 05368, 05345, 09282, 10295, 12201, 12303, 12328, 13100, 13115, and 13180.
Consumers and healthcare providers should stop using the affected products and contact Amerx Health Care Corp. for further instructions or a refund. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
- Manufacturer
- Amerx Health Care Corp.
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 21,108
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 (10)
- Lot codes: 05368
- 05345
- 09282
- 10295
- 12201
- 12303
- 12328
- 13100
- 13115
- and 13180.
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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