Events

Rappel de Device Recall Zilver 518 Vascular Self Expanding Stent

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 Cook Ireland Ltd..

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
    61451
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2309-2012
  • Date de mise en oeuvre de l'événement
    2012-01-05
  • Date de publication de l'événement
    2012-09-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108136
  • 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
    Stent, iliac - Product Code NIO
  • Cause
    Cook ireland received a product complaint from japan on december 22nd, 2011. the complainant reported that a 5 french zilver vascular stent (part number ziv5-18-125-8-80 from lot# cf694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. after further examination, the user determined that the product was a 6 french zilver vascular stent (part number ziv6-35.
  • Action
    The firm, Cook Medical, sent a letter dated February 13, 2012 to foreign consignee. The letter described the product, problem and actions taken. The firm stated that re-training of the relevant personnel has been carried out; they will continue to monitor to identify potential emerging trends and further corrective and preventive action will be considered in an effort to avoid the recurrence of similar events. If you have any question contact in US: Customer Relations Manager at 800.346.2686.ext 2222 or email: rita.harden@cookmedical.com; OUS: Customer Quality Supervisor at +353 61 239343.

Device

Device Recall Zilver 518 Vascular Self Expanding Stent
  • Modèle / numéro de série
    Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Japan.
  • Description du dispositif
    Zilver 518 Vascular Self Expanding Stent || The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
  • Manufacturer
    Cook Ireland Ltd.

Manufacturer

Cook Ireland Ltd.
  • Adresse du fabricant
    Cook Ireland Ltd., O'holloran Road,, National Technological Park, Limerick, Peroc Ireland
  • Société-mère du fabricant (2017)
    Cook Group Incorporated
  • Source
    USFDA