Events

Rappel de Device Recall EVICEL

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ethicon, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63254
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0111-2013
  • Date de mise en oeuvre de l'événement
    2012-07-02
  • Date de publication de l'événement
    2012-10-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113110
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Syringe, piston - Product Code FMF
  • Cause
    Ethicon and omrix biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a pressure regulator to administer evicel; these events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in close proximity to the tissue surface. the field correction initiated is to provide the recommend.
  • Action
    Ethicon sent a notification letter "Urgent Product Information EVICEL Fibrin Sealant (Human) All Lots and Product Codes" dated June 27, 2012, to all affected customers. Notifications were sent via UPS on July 2, 2012. The notification informed customers of the identified risks and included instructions for use. The notification included a business reply card consignees were requested to fill out and return. Customer were notified by a notification titled "Urgent Product Information Omrix Pressure Regulator All Product Codes" that was sent by Ethicon on August 1, 2012, as a follow up to the letter dated June 27, 2012. The notification informed consignees of the identified risks and included instructions for use. Customers were notified that a company representative would visit them to confirm receipt of the notification and to ensure the enclosed label has been affixed correctly on all Omrix Pressure Regulators. For further questions please call 1-877-384-4266.

Device

Device Recall EVICEL
  • Modèle / numéro de série
    To include all lots and product codes for EVICEL and Omrix pressure regulators.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Canada, European Union, Singapore, Israel, Mexico and Brazil.
  • Description du dispositif
    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.

Manufacturer

Ethicon, Inc.
  • Adresse du fabricant
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA