Events

Recall of B Braun Cavafix Catheter

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

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
    16503
  • Event Initiated Date
    2014-04-10
  • 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: B Braun New Zealand Ltd, 23 Falcon Street, Parnell, AUCKLAND 1052
  • Reason
    In the course of internal quality checks the manufacturer discovered that during aging of these products it may come to a blooming of stabilizers of the catheter material on the surface of the catheters. to date, no harm or any other adverse patient outcome which could be associated to the above described observation has been reported to b. braun melsungen ag.
  • Action
    Product to be returned to supplier

Device

B Braun Cavafix Catheter

Manufacturer

B Braun Melsungen AG