FDA-Device2014-12-10Class II
Amerigel Post-op Surgical Kits Wound management
Amerx Health Care Corp.
Hazard
Formulation deviation
Sold states
Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, 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, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
Affected count
79,677
Manufactured in
1300 S. Highland Avenue, N/A, Clearwater, FL, United States
Products
Amerigel Post-op Surgical Kits Wound management
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0498-2015Don't want to check this manually?
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