Events

Recall of Nortec patient lifting sling

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Zenitec Holdings 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
    20957
  • Event Initiated Date
    2017-01-18
  • 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: Zenitec Holdings Ltd, 135-137 Ettrick St, Invercargill 9840
  • Reason
    There have been four recorded cases of failure of the keyhole clip that attaches a sling to a pivot framed hoist. these keyhole clips are the black plastic component this is attached to the sling by means of a webbing strap threaded through a slot. the affected clips have all broken at the slot., the fault has been tracked to two batches of product which were made with incorrect machine settings by the clip manufacturer.
  • Action
    Product to be exchanged

Device

Nortec patient lifting sling

Manufacturer

Zenitec Holdings Ltd