The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2641-2014·Announced 2014-09-24

Amerx Recalls Amerigel Daily Dressing for Unapproved Labeling Claims

Amerx Health Care Corp. is recalling Amerigel Daily Dressing Advanced 3-in-1 Hydrogel because the product labeling includes unapproved claims for antimicrobial and autolytic debridement.

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 due to unapproved labeling claims, which fits the rubric for moderate severity involving minor labeling errors or voluntary precautionary recalls without reported injuries.

Plain-English summary

Amerx Health Care Corp. is voluntarily recalling approximately 1,740 units of Amerigel Daily Dressing Advanced 3-in-1 Hydrogel, catalog number A2003. The product consists of 30 single-use foil packets, each containing 1g of hydrogel, and is used for wound management. The recall is limited to lot code 2WD07.

The recall was initiated because the product labeling contains claims that the dressing is antimicrobial and provides autolytic debridement. The U.S. Food and Drug Administration has not approved these specific labeling claims for this device. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected product was 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 providers who have this specific lot of the product should stop using it and contact Amerx Health Care Corp. for instructions on how to return the product or obtain a refund.

The recalled product

Product
Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. 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 (1)

  • Lot codes: 2WD07.

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

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 →

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