Events

Recall of Bard 2-Way Foley Catheters and 2-Way Council Tip Foley Catheters

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
    19606
  • Event Initiated Date
    2016-01-07
  • 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
    Manufacturer has identified that the instructions for use (ifu) included with the products listed in attachment #1 distributed from june 2013 to june 2015 provide the incorrect inflation volume. the inflation volume provided on the catheter's valve cap does state the correct inflation volume. the ifu contains a chart entitled recommended inflation volumes with incorrect volumes.
  • Action
    Instructions for use to be updated

Device

Bard 2-Way Foley Catheters and 2-Way Council Tip Foley Catheters
  • Model / Serial
    Model: 0165SI08, 0165SI10, 0165SI12, 0165SI14, 0165SI16, 0165SI18, 0165SI20, 0165SI22, 0165SI24, 0165SI26, 0165SI28,0165SI30 0196SI16.0196SI18, 0196SI20 and 0196SI22, Affected:
  • Manufacturer
    C R Bard Inc

Manufacturer

C R Bard Inc