Events

Rappel de Device Recall INTEGRA NEUROSCIENCESStylet for Ventricular CatheterNon Sterile for Single Use Only

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 Neurosciences PR, Inc..

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
    60599
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1047-201
  • Date de mise en oeuvre de l'événement
    2011-11-28
  • Date de publication de l'événement
    2012-02-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-10-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105926
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Cause
    The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
  • Action
    Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or LAPAC_CS@Integralife.com For questions call 609-936-2495.

Device

Device Recall INTEGRA NEUROSCIENCESStylet for Ventricular CatheterNon Sterile for Single Use Only
  • Modèle / numéro de série
    1010344, 1011451, 1021637, 1030061, 1032742, 1040738, 1041561, 1052595, 1053121, 1053487, 1080115, 1080148, 1081155, 1082137
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia
  • Description du dispositif
    "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro, NJ***" || Stainless steel stylet for ventricular catheter
  • Manufacturer
    Integra Neurosciences PR, Inc.

Manufacturer

Integra Neurosciences PR, Inc.
  • Adresse du fabricant
    Integra Neurosciences PR, Inc., Carr 402 Norte Km 1.2, Anasco PR 00610
  • Source
    USFDA