Medical device recalls Moderate risk

Amerx Health Care Corp. recalls Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.

Recall date
May 20, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2249-2016
FDA classification
Class II
Brand / firm
Amerx Health Care Corp.
Sold / distributed
AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska. Bahrain & Colombia.

Why it was recalled

Product did not meet specifications for Zinc Acetate (OOS).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.

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