Device Recall Amerigel

  • Model / Serial
    ALL Lots - 11406, 11414, 12439, 12466, and 02521.
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. || Wound Management.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Amerx Health Care Corp., 1300 S. Highland Avenue, Clearwater FL 33756
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

7 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot # 668
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
  • Manufacturer
  • Model / Serial
    Lot #3WD02, Lot #3WD03, Lot #3WD04 and Lot #3WD05.
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Distributed in the states of FL and NJ.
  • Product Description
    Amerigel Wound Dressing 1 oz. tube
  • Manufacturer
  • Model / Serial
    Lot codes: 3WD02, 3WD03, 3WD04, and 3WD05
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Amerigel Wound Dressing Maximum Strength CAT# A2001. || Wound management.
  • Manufacturer
  • Model / Serial
    Lot codes: 05368, 05345, 09282, 10295, 12201, 12303, 12303, 12328, 13100, 13115, and 13180.
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. || Wound management.
  • Manufacturer
2 more