Recall of GHAJAR GUIDE VENTRICULOSTOMY KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    59418
  • Event Risk Class
    II
  • Event Initiated Date
    2011-01-07
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    This recall is an expansion of the december 2010 codman disposable twist drill recall. codman has recently identified a packaging problem in certain lots of codman disposable drills. cracks have been identified in the sterile package tray in which these products are contained. the product in a cracked package may not be sterile and could result in an increased risk of infection should it be used.

Device

  • Model / Serial
    Model Catalog: 80-1185 (Lot serial: MB219); Model Catalog: 80-1185 (Lot serial: KB216); Model Catalog: 80-1185 (Lot serial: BB317); Model Catalog: 80-1185 (Lot serial: BB235); Model Catalog: 80-1185 (Lot serial: 421302); Model Catalog: 80-1185 (Lot serial: 427693); Model Catalog: 80-1185 (Lot serial: 424871); Model Catalog: 80-1185 (Lot serial: 424870); Model Catalog: 80-1185 (Lot serial: 429015); Model Catalog: 82-6607 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 80-1190 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 80-1200 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    GHAJAR GUIDE VENTRICULOSTOMY KIT
  • Manufacturer

Manufacturer