The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2640-2014·Announced 2014-09-24

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.

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 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.
Category
Medical Device — Wound Management
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

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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