Events

Recall of Bard Australia Pty Ltd - Catheter balloon inflation system, single-use

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Perouse Medical.

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
    21537
  • Event Initiated Date
    2017-06-13
  • 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: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, 54 Carbine Road, Mt Wellington, AUCKLAND
  • Reason
    The manufacturer has identified that the caliber inflation device may be at risk of containing a crack in the primary packaging, resulting in a breach of the sterile barrier.
  • Action
    Product to be returned to supplier

Device

Bard Australia Pty Ltd - Catheter balloon inflation system, single-use
  • Model / Serial
    Model: , Affected: Product Code CL3030, Lot numbers 15045606, 15075821
  • Manufacturer
    Perouse Medical

Manufacturer

Perouse Medical