The Recall Desk
ModerateFDA (Devices)·Z-0498-2015·Announced 2014-12-10

Amerx Health Care Recalls Amerigel Post-op Surgical Kits Due to Formulation Deviation

Amerx Health Care Corp. is recalling 79,677 Amerigel Post-op Surgical Kits due to a formulation deviation. The affected kits 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is described generally as a 'formulation deviation' without specific details on high-risk pathogens or structural defects, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Amerx Health Care Corp. is recalling 79,677 units of Amerigel Post-op Surgical Kits, Model # A2002. The recall is due to a formulation deviation. The affected lots include JCA0086 through JCA0106.

The recalled products were distributed nationwide in the United States, including all 50 states, the District of Columbia, and U.S. territories. Distribution also extended internationally to Canada, England, Africa, and Australia.

The source text does not specify the specific nature of the formulation deviation or any reported adverse health consequences. Consumers and healthcare providers should check their inventory for the affected model and lot numbers and contact the manufacturer for further instructions.

The recalled product

Product
Amerigel Post-op Surgical Kits Wound management
Manufacturer
Amerx Health Care Corp.
Category
Medical Device — Wound Management
Hazard
Affected units
79,677

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 (20)

  • Model # A2002
  • Lot #s: JCA0086
  • JCA0087
  • JCA0088
  • JCA0089
  • JCA0090
  • JCA0091
  • JCA0092
  • JCA0093
  • JCA0094
  • JCA0095
  • JCA0096
  • JCA0097
  • JCA0098
  • JCA0099
  • JCA0100
  • JCA0101
  • JCA0102
  • JCA0103
  • JCA0104

Distribution

Distributed nationwide across the United States.

The notice also names 47 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 →

Related recalls

Same manufacturer · Amerx Health Care Corp.

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Same hazard · formulation deviation

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