Device Recall Amerigel Hydrogel Saturated Gauze Dressing

  • 모델명 / 제조번호(시리얼번호)
    Lot codes: 05368, 05345, 09282, 10295, 12201, 12303, 12303, 12328, 13100, 13115, and 13180.
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. || Wound management.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Amerx Health Care Corp., 1300 S. Highland Avenue, Clearwater FL 33756
  • 제조사 모회사 (2017)
  • Source
    USFDA