Events

Recall of Aircraft Medical McGrath MAC Video Laryngoscope Blade Size#2

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Aircraft Medical Ltd.

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
    17745
  • Event Initiated Date
    2014-11-20
  • 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: Covidien NZ Ltd, Level 3, Building 5, Central Park Corporate Centre, 666 Great South Road, Penrose, AUCKLAND 1051
  • Reason
    When a blade from an affected lot is fited to certain mac video laryngscopes it may be difficult to get the blade clip to engage onto the tooth on the handle. this increases the possibility of blade becoming disconnected during intubation specifically when the device is being retracted from the mouth of the patient.
  • Action
    Product to be returned to supplier

Device

Aircraft Medical McGrath MAC Video Laryngoscope Blade Size#2
  • Model / Serial
    Model: 350-017-000, Affected: Lot numbers: 3121202, 13122301, 13042401, 14030501, 14031814 and 14051616
  • Manufacturer
    Aircraft Medical Ltd

Manufacturer

Aircraft Medical Ltd
  • 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