Events

Recall of Baxter Healthcare Bladder Irrigation Connector

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

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
    16052
  • Event Initiated Date
    2014-01-22
  • 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: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Reason
    Manufacturer has been reviewing the stability data generated to support labelling claims on its products and found that the microbial barrier requirements, provided by means of the packaging material to guarantee sterility of the product were not met for the named product code. as a result the manufacturer cannot guarantee sterility of the product over the whole claimed shelf life. the medical risk has been assessed as high and therefore manufacturer has made the decision to recall all batches of this product code.
  • Action
    Product to be returned to supplier

Device

Baxter Healthcare Bladder Irrigation Connector

Manufacturer

Baxter Healthcare Corporation SA