Events

Recall of Level 1 Hotline Fluid Warming Sets

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Smiths Medical ASD 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
    16408
  • Event Initiated Date
    2014-03-21
  • 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: Smiths Medical Australasia Pty Ltd, c/o KPMG, KPMG Centre, 18 Viaduct Harbour Avenue, Auckland
  • Reason
    Smiths medical has become aware of an issue with a limited number of warming sets with the potential for leakage from the injection port at the top of the warming set. if fluid leaks at the injection port, the leak is readily detectable by the clinician who would stop using the warming set and obtain a replacement. this could present a minor delay in therapy while a replacement warming set is obtained.
  • Action
    Product to be returned to supplier

Device

Level 1 Hotline Fluid Warming Sets
  • Model / Serial
    Model: Models: L-70 and L-80, Affected: 73 and 5 specific lots respectively
  • Manufacturer
    Smiths Medical ASD Inc

Manufacturer

Smiths Medical ASD Inc