Events

Recall of Unomedical Suction System Tubing (non-sterile)

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
    18739
  • Event Initiated Date
    2015-07-07
  • 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: Convatec (New Zealand) Ltd, WHK Gosling Chapman, Level 6, 51-53 Shortland Street, Auckland
  • Reason
    An internal assessment of product complaints has confirmed that these devices are not meeting the manufacturer's specifications. specifically, the connector part for application to the suction devices in these lots, has failed to meet its required durability. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
  • Action
    Product to be returned to supplier

Device

Unomedical Suction System Tubing (non-sterile)
  • Model / Serial
    Model: 533.25.200, 533.25.300, 533. 25.450, 533.30.300, Affected: Selected lot numbers
  • Manufacturer
    Unomedical Sdn Bhd

Manufacturer

Unomedical Sdn Bhd