Events

Recall of Temperature Controller, Biomedicus Biocal 370

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Medtronic 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
    22619
  • Event Initiated Date
    2018-02-15
  • 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: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • Reason
    The manufacturer has collaborated with regulators to develop a revised cleaning protocol for the bio cal devices, but after significant efforts have been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. as a result, an updated cleaning protocol will not be developed and it has been determined that the best course of action is to request bio cal users to discontinue use and dispose of bio cal devices.
  • Action
    Product to be destroyed

Device

Temperature Controller, Biomedicus Biocal 370
  • Model / Serial
    Model: Model Numbers 370 and 370I, Affected:
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NZMMDSA