Events

Recall of Smiths CADD-Solis Ambulatory Infusion Pumps

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
    18586
  • Event Initiated Date
    2015-05-27
  • 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 an intermittent occurrence of binding of the locking assembly on some cadd-solis pumps. binding of the cassette/ keypad lock can occur after latching the cadd-solis medication cassette reservoir or administration set "disposable" to the pump. when binding occurs, it can prevent the key from fully rotating the cassette/ keypad lock to the locked (engaged) position. if the user is unable to fully engage the cassette/ keypad lock the keypad will be locked and the pump cannot be started in pca mode.
  • Action
    Product to be modified

Device

Smiths CADD-Solis Ambulatory Infusion Pumps
  • Model / Serial
    Model: Model Numbers: 2111 (grey keypad), 2112 (yellow keypad), 2120 (VIP), Affected: Serial Number 1061043 through 1067598
  • Manufacturer
    Smiths Medical MD Inc

Manufacturer

Smiths Medical MD Inc