The Recall Desk
HighFDA (Devices)·Z-0497-2015·Announced 2014-12-10

Amerx Health Care Recalls Amerigel Hydrogel Wound Dressing Due to Formulation Deviation

Amerx Health Care Corp. is recalling Amerigel Hydrogel Wound Dressing units due to a formulation deviation. The recall covers 340,896 units distributed nationwide and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses, placing this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Amerx Health Care Corp. is recalling 340,896 units of Amerigel Hydrogel Wound Dressing. The recall was initiated due to a formulation deviation in the product. The affected product is used for wound management.

The recall includes Model # A2001 with specific lot numbers: YWD13, YWD15, YWD16, 2WD01, 2WD02, 2WD03, 2WD04, 2WD05, 2WD08, 2WD09, 2WD11, 2WD13, 2WD14, 2WD15, 2WD17, 2WD18, 3WD01, 3WD02, 3WD03, 3WD04, and 3WD05. The agency has classified this recall as Class II.

The affected units were distributed nationwide in the United States, including all states, the District of Columbia, and U.S. territories. The product was also distributed internationally to Canada, England, Africa, and Australia. Consumers and healthcare providers should check their inventory for the specific model and lot numbers listed and stop using the product if it matches the recall criteria.

The recalled product

Product
Amerigel Hydrogel Wound Dressing Wound management
Manufacturer
Amerx Health Care Corp.
Category
Medical Device — Wound Dressing
Hazard
Affected units
340,896

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 # A2001
  • Lot #s: YWD13
  • YWD15
  • YWD16
  • 2WD01
  • 2WD02
  • 2WD03
  • 2WD04
  • 2WD05
  • 2WD08
  • 2WD09
  • 2WD11
  • 2WD13
  • 2WD14
  • 2WD15
  • 2WD17
  • 2WD18
  • 3WD01
  • 3WD02
  • 3WD03

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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