Events

Rappel de Device Recall CryoValve

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 Cryolife 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
    27949
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0516-04
  • Date de mise en oeuvre de l'événement
    2003-11-10
  • Date de publication de l'événement
    2004-02-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-05-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30787
  • 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
    Heart-Valve, Allograft - Product Code MIE
  • Cause
    The firm received additional information from the procurement agency indicating that yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis.
  • Action
    Consignee was first notified by telephone on 11/10/2003, with a follow up letter sent 12/10/2003. If the tissue had been implanted the consignee was advised to forward that information to CryoLife''s Regulatory Department-Field Assurance. If the tissue had not been implanted the consignee was advised not to implant or further distribute the tissue. They were instructed to remove the tissue from the implantable inventory and to place it into quarantine pending return to CryoLife. A self addressed, stamped postcard was included to affirm receipt of notification and to acknowledge that the tissue had been placed into quarantine.

Device

Device Recall CryoValve
  • Modèle / numéro de série
    Donor number: 71237, Serial number: 8214013, Model number: PV00
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    The tissue was issued to one hospital in CA.
  • Description du dispositif
    CryoValve, Pulmonary Valve & Conduit
  • Manufacturer
    Cryolife Inc

Manufacturer

Cryolife Inc
  • Adresse du fabricant
    Cryolife Inc, 1655 Roberts Blvd Nw, Kennesaw GA 30144-3632
  • Source
    USFDA