FDA-Device2016-07-27Class II

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

Amerx Health Care Corp.
Hazard

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

Sold states
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.
Affected count
6,993 Units
Manufactured in
1300 S Highland Ave, N/A, Clearwater, FL, United States
Products
Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2249-2016

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