Device Recall Amerigel

  • 모델명 / 제조번호(시리얼번호)
    ALL Lots - 11406, 11414, 12439, 12466, and 02521.
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Amerigel Hydrogel Gauze Dressing 2 x 2, 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 7 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot #3WD02, Lot #3WD03, Lot #3WD04 and Lot #3WD05.
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of FL and NJ.
  • 제품 설명
    Amerigel Wound Dressing 1 oz. tube
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot #3WD05.
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of FL and NJ.
  • 제품 설명
    Amerigel Wound Dressing 55 gallons/drum
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot codes: 3WD02, 3WD03, 3WD04, and 3WD05
  • 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 Wound Dressing Maximum Strength CAT# A2001. || Wound management.
  • Manufacturer
  • 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
  • 모델명 / 제조번호(시리얼번호)
    Lot codes: JCA0086 through JCA0106.
  • 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 Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages || CAT # A2002. || Wound management.
  • Manufacturer
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