Devices

Device Recall EVICEL

  • Model / Serial
    To include all lots and product codes for EVICEL and Omrix pressure regulators.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Canada, European Union, Singapore, Israel, Mexico and Brazil.
  • Product Description
    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

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Evicel Accessory Device
  • Model / Serial
    Lot 17-0102
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.