Events

Rappel de Device Recall AORTIC ARCH CANNULA

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
    74490
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2147-2016
  • Date de mise en oeuvre de l'événement
    2016-06-22
  • Date de publication de l'événement
    2016-07-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147758
  • 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
    Sorin group usa is recalling aortic arch cannulae (part numbers na-55x7 and na-55x8) because the distal end may be less than specified. the defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.
  • Action
    The firm, LivaNova, sent an "Urgent Safety Alert" field communication letter dated June 22, 2016 via certified mail to consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to: check your inventory to determine if you own Cannulae, if no inventory, complete the response form and return it per instructions indicated on form.; check the tip angle to determine if it is conforming to specifications, if specifications not met, file a complaint through your normal process whether you decide to keep it, use it or return it to Sorin Group; If you are not willing to use it, return affected product parts to Sorin Group USA,; contact Customer Service at 1-800-650-2623 or email CustomerService@livanova,com to have a RMA issued, and complete and return the Customer Response Form no later than July 20, 2016 via Fax at 303-467-6502 or by e-mail to USFSN@livanova.com. If you need support for the execution of these actions, please contact your LivaNova sales representative or call Customer Service at 1-800-650-2623 (Monday to Friday 8AM to 5PM MT). For questions regarding this notice, please contact Customer Service at 1-800-650-2623 (Monday to Friday 8AM to 5PM MT) or e-mail USFSN@livanova.com.

Device

Device Recall AORTIC ARCH CANNULA
  • Modèle / numéro de série
    Lots: 1505600017 ; 1505600018 ; 1506500005 ; 1509200078 ; 1513100112 ; 1513900027 ; 1513900028 ; 1514700045 ; 1516600192 ; 1516800126 ; 1517800004 ; 1519500037 ; 1520100049 ; 1520100050 ; 1520900031 ; 1520900033 ; 1521600126 ; 1523000093 ; 1523600120 ; 1525100023 ; 1525800026 ; 1526500032 ; 1526500033 ; 1526500034 ; 1526500072 ; 1527200050 ; 1527200051 ; 1527200052 ; 1527800163 ; 1529300026 ; 1529300027 ; 1529300028 ; 1533500033 ; 1534200034 ; 1601900027 ; 1601900028 ;
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: LA, Ml, MO, OH, TN, and TX; and countries of: Italy and Canada.
  • Description du dispositif
    AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) || Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Adresse du fabricant
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
  • Société-mère du fabricant (2017)
    LivaNova PLC
  • Source
    USFDA