Events

Recall of McGRATH MAC Video Laryngoscope Blade Size #2

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Covidien Pty 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
    RC-2014-RN-01239-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01239-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The blade retaining clip may be difficult to engage due to an error in the manufacturing process. this issue may increase the possibility of the blade becoming disconnected during intubation when the device is being retraced from the patient. inability or delay of intubation of a patient in critical condition could result in serious injury.
  • Action
    Customers are requested to contact Covidien to arrange for the return of any affected product. Covidien will provide credit to affected customers. This action has been closed-out on 19/08/2016.

Device

McGRATH MAC Video Laryngoscope Blade Size #2
  • Model / Serial
    McGRATH MAC Video Laryngoscope Blade Size #2Product code: 350-017-000 Lot numbers: 13121202, 13122301, 13042401, 14030501, 14031814, and 14061616. ARTG number: 192324
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty 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
    DHTGA