Events

Recall of OMRIX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29728
  • Event Risk Class
    Class 3
  • Event Number
    Z-1497-04
  • Event Initiated Date
    2004-08-06
  • Event Date Posted
    2004-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34432
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Syringe, Piston - Product Code FMF
  • Reason
    5 ml crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port .
  • Action
    American Red Cross was notified of the recall on July 25, 2004. Recall letter to the ARC direct accounts was sent out on 8/9/2004.

Device

OMRIX
  • Model / Serial
    Lot 0404 exp. Oct. 2008; Lot 0417 exp. Jan. 2009; Lot 0419 exp. Jan. 2009.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped from Israel to the American Red Cross distribution center in Louisville, KY. From there, the ARC would ship the product to other distributors and/or directly to 46 hospitals nationwide. There are no govt accounts.
  • Product Description
    Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington, DC || 20006, Manufactured by: Medimop Medical Projects Ltd, for OMRIX biopharmaceuticals, Utd, MDA blood bank, Sheba Hospital, Romat-Gan, PO8 888, Kiryat Ono 55000 Israel
  • Manufacturer
    Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst.

Manufacturer

Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst.
  • Manufacturer Address
    Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst., Magen David Adom Blood Services Ctr.,, Sheba Hospital, Ramat Gan Israel
  • Source
    USFDA