Events

Rappel de Device Recall MassTRANSIT Infusion Catheter Kit

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 Cordis 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
    50154
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0604-2009
  • Date de mise en oeuvre de l'événement
    2008-06-30
  • Date de publication de l'événement
    2008-12-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-01-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74869
  • 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
    Continuous Flush Catheter - Product Code KRA
  • Cause
    Two lots of cordis neurovascular masstransit infusion catheter kits has the potential for sterile ptfe contamination within the inner lumen of the catheter.
  • Action
    A Medical Device Recall letter, dated 6/30/2008, and Acknowledgement Form were sent overnight. The firm asked customers to set aside any affected product in a manner that ensures it will not be used. Customers are asked to review, sign and return the enclosed Acknowledgement Form directly to Cordis Neurovascular. Customers can either return any product with reference to the RA# on the form, or contact their local sales reps to facilitate return of the affected product. Customers will receive a credit for the units they return. If any affected product has been forwarded to another facility, the facility should be contacted to arrange return of the product. If there are any additional questions, Customer Service may be also be contacted at 800-551-7683.

Device

Device Recall MassTRANSIT Infusion Catheter Kit
  • Modèle / numéro de série
    Lot Number 13358689 and 13350390.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution --- including states of Colorado, Connecticut, Florida, Minnesota, Nebraska, Nevada, Ohio, Oregon, and Virginia.
  • Description du dispositif
    MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular || Intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurovascular, Peripheral Vascular and Coronary Vascular systems and for superselective angiography of peripheral and coronary vasculature.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Adresse du fabricant
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA