Amerx Health Care Corp. recalls Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.

Recall date

February 25, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1797-2015

FDA classification

Class II

Brand / firm

Amerx Health Care Corp.

Sold / distributed

Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.

Why it was recalled

Nonapproved labeling claims (Sterile)

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 Gauze Dressing 2 x 2, A5002. Wound Management.