Devices

Device Recall SKINPREP Protective wipes

  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: Range from U24401 through U29801;  Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, NH, NJ, NY, PA, TX, and WI, and the countries of Canada and Netherlands.
  • 제품 설명
    BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). || The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
  • Manufacturer
    BioDerm, Inc.
  • 1 Event

제조사

BioDerm, Inc.
  • 제조사 주소
    BioDerm, Inc., 12320 73rd Ct, Largo FL 33773-3011
  • 제조사 모회사 (2017)
    Bioderm Inc.
  • Source
    USFDA

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

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Device Recall SKINPREP Protective Wipes
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: Range from U24401 through U29801; Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, NH, NJ, NY, PA, TX, and WI, and the countries of Canada and Netherlands.
  • 제품 설명
    BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). || The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
  • Manufacturer
    BioDerm, Inc.