Events

Rappel de Integra Cranial Access 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. d.b.a. Integra Pain Management.

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
    66186
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2260-2013
  • Date de mise en oeuvre de l'événement
    2013-09-04
  • Date de publication de l'événement
    2013-09-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121671
  • 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 HGB
  • Cause
    Integra is recalling certain lots of cranial access kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.
  • Action
    Integra sent an Urgent Voluntary Medical Device Recall letter dated September 4, 2013, to all affected customers that have been shipped unexpired affected product lots of Integra¿ Cranial Access Kits, Catalogue No.'s INSHITH, INSHITHND, INSHITHRZN.The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review their inventory and immediately stop the use or distribution of any affected product. Customers were instructed to identify and report to Integra if they do or do not have any of the affected product lots. Customers were advised how to return any affected product lot numbers in their possession. Effectiveness Checks will be conducted to determine the level of customers who: - Integra has verified, have been notified, and / or acknowledged the recall either by returning the acknowledgement form. - Indicate they will be returning / have returned unexpired affected product lots of kits. Any affected product lot numbers that are returned from consignees will be forwarded to the Integra Salt Lake City, UT facility for final disposition per its site QMS processes. Customers with questions were advised to contact Customers Service at 1-855-532-1723. For questions regarding this recall call 801-886-9505.

Device

Integra Cranial Access Kit
  • Modèle / numéro de série
    INSHITH Lots: W1205183,,W1207036,,W1209165,,W1209166,,W1209168,,W1210156,,W1210157,,W1210158,,W1210159,,W1210160,,W1211021,,W1211030,,W1211135,,W1211136,,W1211137,,W1212170 INSHITHND Lots: W1210230 INSHITHRZN Lots: W1209156,,W1211182,,W1212090,,W1212125,,W1212178,,W1301258,,W1302005,,W1302031,,W1303148
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including CA, CO, FL, IN, KS, NC, NV, NY, OK, TN, TX, VA, WA, and WI.
  • Description du dispositif
    Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN || The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.
  • Manufacturer
    Integra LifeSciences Corp. d.b.a. Integra Pain Management

Manufacturer

Integra LifeSciences Corp. d.b.a. Integra Pain Management
  • Adresse du fabricant
    Integra LifeSciences Corp. d.b.a. Integra Pain Management, 3498 West 2400 South #1050, Salt Lake City UT 84119
  • Société-mère du fabricant (2017)
    Integra LifeSciences Holdings Corporation
  • Source
    USFDA