Events

Rappel de Device Recall Sarns Soft Flow Aortic Cannulae

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 Corporation.

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
    63407
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0456-2013
  • Date de mise en oeuvre de l'événement
    2012-11-21
  • Date de publication de l'événement
    2012-12-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113705
  • 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
    The presence of plastic flash was identified at the tip of certain lots of sarns soft-flow aortic cannula. the plastic flash has the potential to detach and contribute to an adverse patient effect. while this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl.
  • Action
    TERUMO sent an URGENT MEDICAL DEVICE RECALL letter dated September 20, 2012, to all affected customers. The letter identified the product, the problem, and the aciton to be taken by the customer. Customers were instructed to remove this cannulae from circulation and return them for credit. Customers with questions should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.

Device

Device Recall Sarns Soft Flow Aortic Cannulae
  • Modèle / numéro de série
    catalog number: 5841 and 5845 and lot number: 0581536 and 0581138.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA.
  • Description du dispositif
    24 Fr 8mm Sft Flow Str Wire W/L || The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Adresse du fabricant
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA