Amerx Recalls Amerigel Post-Op Surgical Kits for Unapproved Labeling Claims
Amerx Health Care Corp. is recalling Amerigel Post-Op Surgical Kits because the product labeling contains 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 due to unapproved labeling claims, which falls under the rubric for minor labeling errors or voluntary precautionary recalls without reported injuries.
Plain-English summary
Amerx Health Care Corp. is voluntarily recalling 116,633 units of Amerigel Post-Op Surgical Kits. The kits, which include Amerigel Wound Dressing, Amerigel Wound Wash, gauze pads, and fabric bandages, are being recalled due to labeling issues. Specifically, the product labeling includes claims about antimicrobial and autolytic debridement that have not been approved by the FDA.
The affected products are identified by lot codes JCA0086 through JCA0106. These kits were 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 facilities should stop using the affected kits and contact Amerx Health Care Corp. for further instructions or a refund. This recall is a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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.
- Manufacturer
- Amerx Health Care Corp.
- Hazard
- Affected units
- 116,633
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: JCA0086 through JCA0106.
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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