Events

Rappel de Device Recall Integra Large Rickham Style Reservoir

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
    67025
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0622-2014
  • Date de mise en oeuvre de l'événement
    2013-11-13
  • Date de publication de l'événement
    2014-01-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-02-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124553
  • 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
    Integra became aware through an adverse complaint trend that rickham style reservoirs with bent or broken connectors that were shipped in sleeve-type packages were found prior to use but after the sterile package was open.
  • Action
    Integra sent an Urgent Voluntary Medical Device Recall letter dated November 13, 2013, 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 for the affected product and if located stop using immediately. Customers were asked to complete the attached form and return it to Integra as indicated and keep a copy of the form for their records. Once the form was received by Integra they will send an RMA number, directions to return the product, and input an order to replace the quantity they indicated on the form. Customers with questions were instructed to call 1-855-532-1723. For questions regarding this recall call 855-532-1723.

Device

Device Recall Integra Large Rickham Style Reservoir
  • Modèle / numéro de série
    1094085, 1101479, 1101647, 1102403, 1102807, 1104174, 1110043, 1120817, 1130797, 1131331, 1131660
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including FL, NE, WI, WA, CT, ND, AL, NY, NH, OR, OK, MN, and TX. Internationally to Belgium, Czech Republic, Germany, France, Great Britian, Italy, Poland, and Portugal.
  • Description du dispositif
    Integra Large Rickham -Style Reservoir || Rx Only Sterile for Single Use Only || Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA || NL 850-1132 || Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.