Events

Rappel de Device Recall Integra(R) Jarit(R) Monopolar Cable

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
    64357
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0886-2013
  • Date de mise en oeuvre de l'événement
    2013-02-12
  • Date de publication de l'événement
    2013-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115922
  • 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
    Coagulator-cutter, endoscopic, unipolar (and accessories) - Product Code KNF
  • Cause
    Addendum to the instructions for use. the addendum emphasizes the warnings and precautions already contained in the device's ifu and also provides additional warnings and precautions that are applicable to the use of electrosurgical equipment in health care facility environments.
  • Action
    Integra sent an Urgent Medical Device Correction Field Safety Notice letter dated February 12, 2013 and a copy of the Instructions for Use addendum to all affected customers. The letter identified the product, nature of the issue and actions to be taken. Customers were requested to examine their inventory for the affected product and include a copy of the addendum to that inventory. Customers were instructed to complete and return the Acknowledgement Return Form and provide a copy of the IFU addendum to any of their customers that had purchased the Jarit(R0 Monopolar Cable. For questions call Integra Surgical Customer Service at 800-431-1123.

Device

Device Recall Integra(R) Jarit(R) Monopolar Cable
  • Modèle / numéro de série
    Catalogue No. 600-290. All lots distributed since 2004.
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including Canada.
  • Description du dispositif
    Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). || For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.