Amerx Health Care Recalls Amerigel Daily Dressing Packets Due to Formulation Deviation
Amerx Health Care Corp. is recalling 1,740 units of Amerigel Daily Dressing Packets due to a formulation deviation. The affected products were distributed nationwide and internationally.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving a potential but unreported risk.
Plain-English summary
Amerx Health Care Corp. is recalling 1,740 units of Amerigel Daily Dressing Packets, a wound management product. The recall is being conducted due to a formulation deviation. The affected product is identified by Model # A2003 and Lot # 2WD07.
The recalled products were distributed nationwide in the United States, including all 50 states, the District of Columbia, and U.S. territories. The products were also distributed internationally to Canada, England, Africa, and Australia.
Consumers who have this product should stop using it and contact Amerx Health Care Corp. for further instructions.
The recalled product
- Product
- Amerigel Daily Dressing Packets 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 (2)
- Model # A2003
- Lot #s: 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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