Home / Recalls / Medical Devices
Amerx Health Care Corp. recalls Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound man
Recalled September 24, 2014 · FDA recall Z-2639-2014 · Amerx Health Care
Hazard
Not approved labeling claims (antimicrobial and autolytic debridement) · FDA Class II
Units
21,108 units
Sold at
Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.
Description
Not approved labeling claims (antimicrobial and autolytic debridement)
Product
Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
Manufacturer(s)
Amerx Health Care Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →