Events

Rappel de Device Recall Terumo Custom Cardiovascular and Perfusion Procedure Kits

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 Terumo Cardiovascular Systems Corp.

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
    58185
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0159-2015
  • Date de mise en oeuvre de l'événement
    2011-03-01
  • Date de publication de l'événement
    2014-10-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-11-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98953
  • 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
    Cardiovascular procedure kit - Product Code OEZ
  • Cause
    Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line.
  • Action
    Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions: Clamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure. Contact Terumo CVS Customer Service to report the defect and arrange return of the unit: 800-521-2818.

Device

Device Recall Terumo Custom Cardiovascular and Perfusion Procedure Kits
  • Modèle / numéro de série
    Catalog Number: 6XXXX Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22.  Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0.  Catalog Number: 7XXXX Lot Numbers: ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13. Manufacturing dates September 7, 2010 through December 13,2010.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
  • Description du dispositif
    Terumo Custom Cardiovascular and Perfusion Procedure Kits || Catalog Codes: Kits with a 5-digit code beginning with the digit 6: || Catalog Number: 6XXXX ; || Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX || Product usage: || The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Adresse du fabricant
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA