The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2639-2014·Announced 2014-09-24

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.

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 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

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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