Amerx Recalls Amerigel Hydrogel Wound Dressing Due to Zinc Acetate Specification Failure
Amerx Health Care Corp. is recalling 6,993 units of Amerigel Hydrogel Wound Dressing Advanced Formula because the product did not meet specifications for Zinc Acetate.
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 the source text does not report any illnesses, injuries, or deaths, and the hazard is a specification failure without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Amerx Health Care Corp. is recalling 6,993 units of Amerigel Hydrogel Wound Dressing Advanced Formula for wound management, 1 oz. The recall involves Lot # 668. The product was distributed in the United States (AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska) and internationally in Bahrain and Colombia.
The recall was initiated because the product did not meet specifications for Zinc Acetate (Out of Specification). The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers who have this product should stop using it and contact Amerx Health Care Corp. for instructions on return or disposal.
The recalled product
- Product
- Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
- Manufacturer
- Amerx Health Care Corp.
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 6,993
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 # 668
Distribution
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- Low