Events

Rappel de Perfusion Tubing Set

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 Sorin Group USA, 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
    57052
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0375-2011
  • Date de mise en oeuvre de l'événement
    2010-10-07
  • Date de publication de l'événement
    2010-11-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95262
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Cause
    Defective product packaging may compromise product sterility.
  • Action
    Sorin Group sent an "URGENT: FIELD SAFETY NOTICE" letter dated October 7, 2010, to all customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to check all affected inventory to exam for holes. Any damaged products were to be returned to Sorin. If no damage was found, product could be used. The customers were also instructed to contact Sorin Cardiopulmonary Customer Service at 1-800-650-2623 to return product and receive replacement; they were to share this information with all personnel who may use this product; and to complete and return the attached Customer Response Form via the self-addressed prepaid envelope provided or fax to (303) 467-6502 as soon as possible. For further information, contact 1-800-650-2623.

Device

Perfusion Tubing Set
  • Modèle / numéro de série
    Lot No. 0923100008, 0923200001, 0923200059, 0930900050, 0932200080, 0932800037, 0935500078, 0935600066, 0935700005, 1000500016, 1000600049, 1001300028, 1001400027, 1002600036, 1004000043, 1004900023, 1004800039, 1006900003, 1007000021, 1008100027, 1008400017, 1008900051, 1009100046, 1011800029, 1012500029, 1012500047, 1013300024, 1013700029, 1015400021, 1015800064, 1018700026, 1020300022, 1022200022, 1022900027
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
  • Description du dispositif
    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500300, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Adresse du fabricant
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Société-mère du fabricant (2017)
    LivaNova PLC
  • Source
    USFDA