Devices

Device Recall EVICEL

  • 모델명 / 제조번호(시리얼번호)
    To include all lots and product codes for EVICEL and Omrix pressure regulators.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) and the countries of Canada, European Union, Singapore, Israel, Mexico and Brazil.
  • 제품 설명
    EVICEL Fibrin Sealant (Human) Rx Only. || Manufacturer: || Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. || Distributed by: || Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. || The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.
  • Manufacturer
    Ethicon, Inc.
  • 1 Event

제조사

Ethicon, Inc.
  • 제조사 주소
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA

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

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Device Recall Evicel Accessory Device
  • 모델명 / 제조번호(시리얼번호)
    Lot 17-0102
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The device was distributed to the following states: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TN, TX, WA, WI, and WV. The device was also distributed to Puerto Rico.
  • 제품 설명
    Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
  • Manufacturer
    Ethicon, Inc.