Events

Recall of Bard L/Med Rad Kit ACVS NZ

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

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
    22930
  • Event Initiated Date
    2018-05-07
  • 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
    It has been reported that the safety mechanism of the scalpel (component number in1951) of lifemed procedure packs as being not engaged, resulting in an un-sheathed blade that could lead to a cut during handling by health care professionals, especially in circumstances where they are unaware of this anomaly.
  • Action
    Manufacturer to issue advice regarding use

Device

Bard L/Med Rad Kit ACVS NZ
  • Model / Serial
    Model: , Affected: Lot Numbers MYBUL289, MYBVL111, MYBUL289
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd