Events

Recall of Unomedical Frazier Suction Instrument

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Unomedical Sdn Bhd.

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
    20428
  • Event Initiated Date
    2016-07-28
  • 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: Convatec (New Zealand) Ltd, WHK Gosling Chapman, Level 6, 51-53 Shortland Street, Auckland
  • Reason
    Ifu being issued due to complaints from the users in relation to breaking of the instrument at the junction of the handle and the metal tubing when pressure is applied at the tip. if the issue were to occur it would result in a loss of suction and loss of visibility in the surgical field.
  • Action
    Instructions for use to be updated

Device

Unomedical Frazier Suction Instrument
  • Model / Serial
    Model: 309.02.006 309.02.008 309.02.008L 309.02.010 309.02.010L 309.02.012 309.02.012L, Affected: All lots
  • Manufacturer
    Unomedical Sdn Bhd

Manufacturer

Unomedical Sdn Bhd