Events

Rappel de Device Recall Integra Peritoneal Introducer Sheaths

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 Integra LifeSciences 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
    57550
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1231-2011
  • Date de mise en oeuvre de l'événement
    2010-12-22
  • Date de publication de l'événement
    2011-02-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96509
  • 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
    Instrument, shunt system implantation - Product Code GYK
  • Cause
    Peritoneal introducer sheaths were incorrectly labeled as 61 cm instead of 46 cm.
  • Action
    Integra Life Sciences sent an Urgent Product Recall letter dated December 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and quarantine any of the affected product. Contact Integra Customer Service at (800) 654-2873, select option 2 to arrange for product returns. Customers were asked to complete the attached "Recall Acknowledgement and Return Form" indicating the current status of quantities of affected product in their inventory. For questions call (609) 936-2237.

Device

Device Recall Integra Peritoneal Introducer Sheaths
  • Modèle / numéro de série
    Catalog Number 901124, Lot Number 162956 510 K - K771529
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including CO, FL, GA, MO, NC, NJ, PA, TX, UT, and WI.
  • Description du dispositif
    Integra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124; Manufacturer Integra NeuroSciences Implants S.A., 2905 Route Des Dolines, 06921 SOPHIA ANTIPOLIS Cedex, France; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08536, USA || Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus. || Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.