Events

Rappel de Device Recall Micro Ventricular Bolt Pressuring Monitoring, Cranial Access, and Drainage Kit

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
    58216
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2171-2011
  • Date de mise en oeuvre de l'événement
    2011-02-22
  • Date de publication de l'événement
    2011-05-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98685
  • 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
    Drills, burrs, trephines & accessories (manual) - Product Code HBG
  • Cause
    Outer box of monitoring kit was mislabeled with the incorrect part number.
  • Action
    Integra LifeSciences Corp. sent an Urgent Product Recall Notification letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to quarantine any affected product and arrange for return to Integra by contacting Integra Customer Service Returns at 1-800-654-2873 (choose option 2) to obtain a Return Merchandise Authorization number and place an order for replacement product. Customers were asked to complete the attached "Recall Acknowledgement and Return Form" indicating whether or not they possess any of the product identified. For any questions regarding this recall call 609-936-2485.

Device

Device Recall Micro Ventricular Bolt Pressuring Monitoring, Cranial Access, and Drainage Kit
  • Modèle / numéro de série
    Lot number 170314.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including CA, CT, GA, HI, IL, KY, MA, NC, NJ, NM. NV, OH, TX, WA, and WI.
  • Description du dispositif
    Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119. || Kit contains components which are used to monitor Intra Cranial Pressure and provide access to the cerebral ventricles for Cerebro-spinal fluid sampling, drainage and fluid injection.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.