Events

Recall of Instruments - Drill bits

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by CareFusion 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
    20909
  • Event Initiated Date
    2016-12-09
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
  • Reason
    Between 1 july 2011 and 30 june 2016, the manufacturer has received 14 reports from customers of corrosion being evident on screws as they are removed from the immediate packaging.
  • Action
    Product to be returned to supplier

Device

Instruments - Drill bits
  • Model / Serial
    Model: , Affected: S -0088, S -0089, S-0090, S -0091
  • Manufacturer
    CareFusion Inc

Manufacturer

CareFusion Inc