Events

Recall of Smiths Medical 100 ml CADD Administrations Set

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Smiths Medical MD 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
    22071
  • Event Initiated Date
    2017-10-13
  • 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
    The manufacturer has become aware that certain non flow-stop cadd medication cassette reservoirs may have been manufactured with an incorrect pressure plate. normally the pressure plate has a tunnel for the pumping tube, however on the affected models there is an arch on the pressure plate and pumping tube is pushed up., under delivery of medication may result from the tubing becoming partially or completely occluded when the affected cassette is attached to the pump.
  • Action
    Product to be returned to supplier

Device

Smiths Medical 100 ml CADD Administrations Set
  • Model / Serial
    Model: 21-7002-24, Affected: Lot Nos: multiple (expiration date range March 2017 and March 2022)
  • Manufacturer
    Smiths Medical MD Inc

Manufacturer

Smiths Medical MD Inc