Events

Recall of Device Recall INTEGRA NEUROSCIENCESStylet for Ventricular CatheterNon Sterile for Single Use Only

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra Neurosciences PR, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60599
  • Event Risk Class
    Class 2
  • Event Number
    Z-1047-201
  • Event Initiated Date
    2011-11-28
  • Event Date Posted
    2012-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105926
  • Notes / Alerts
    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.
  • Extra notes in the data
    Shunt, central nervous system and components - Product Code JXG
  • Reason
    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
  • Model / Serial
    1010344, 1011451, 1021637, 1030061, 1032742, 1040738, 1041561, 1052595, 1053121, 1053487, 1080115, 1080148, 1081155, 1082137
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia
  • Product Description
    "***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.
  • Manufacturer Address
    Integra Neurosciences PR, Inc., Carr 402 Norte Km 1.2, Anasco PR 00610
  • Source
    USFDA