Events

Recall of Civco Needle Guides

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Civco Medical Instruments Co 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
    19683
  • Event Initiated Date
    2016-01-20
  • 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: Culpan Distributors Ltd, Unit 10, 19 Hannigan Drive, Mt Wellington, Auckland
  • Reason
    Disposable large-gauge needle guides from the civco start kits listed have been recalled by the manufacturer., they contain two unintended points of contact on the sides of the needle guide; when assembled, these contact points can pinch the cover in the bracket channel during attachment and breach the cover.
  • Action
    Product to be returned to supplier

Device

Civco Needle Guides

Manufacturer

Civco Medical Instruments Co Inc