FDA-Device2014-09-24Class II
Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
Amerx Health Care Corp.
Hazard
Not approved labeling claims (antimicrobial and autolytic debridement)
Sold states
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.
Affected count
1,740 units
Manufactured in
1300 S. Highland Avenue, N/A, Clearwater, FL, United States
Products
Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2641-2014Don't want to check this manually?
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