Events

Recall of Maquet Statlock IAB

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by C R Bard 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
    20272
  • Event Initiated Date
    2016-06-20
  • 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: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • Reason
    In february 16, 2016 it was discovered that the ifu for the statlock sheath stabilization device was incorrectly packaged with the mega and sensation plus iab.
  • Action
    Instructions for use to be updated

Device

Maquet Statlock IAB
  • Model / Serial
    Model: Statlock IAB 0065000704, Affected: All lots 3000001484 to 3000024495
  • Manufacturer
    C R Bard Inc

Manufacturer

C R Bard Inc