Events

Recall of AURAGAIN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARESTREAM MEDICAL ULC..

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
    49947
  • Event Risk Class
    II
  • Event Initiated Date
    2016-01-12
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Err:509.

Device

AURAGAIN
  • Model / Serial
    Model Catalog: 408 500 000 (Lot serial: >1000 contact mfg); Model Catalog: 408 400 000 (Lot serial: >1000 contact mfg); Model Catalog: 408 300 000 (Lot serial: >1000 contact mfg); Model Catalog: 408 500 000 (Lot serial: -see West Care #); Model Catalog: 408 400 000 (Lot serial: -see West Care #); Model Catalog: 408 300 000 (Lot serial: -see West Care #); Model Catalog: 408 500 000 (Lot serial: 1810863 and lower); Model Catalog: 408 400 000 (Lot serial: 1810863 and lower); Model Catalog: 408 300 000 (Lot serial: 1810863 and lower); Model Catalog: 408 500 000 (Lot serial: 1790075 and lower); Model Catalog: 408 400 000 (Lot serial: 1790075 and lower); Model Catalog: 408 300 000 (Lot serial: 1790075 and lower); Model Catalog: 408 500 000 (Lot serial: except 177996617822391795914); Model Catalog: 408 400 000 (Lot serial: except 177996617822391795914); Model Catalog: 408 300 000 (Lot serial: except 177996617822391795914); Model Catalog: 408 500 000 (Lot serial: 1808911 and lower); Model Catalog: 408 400 000 (Lot s
  • Product Description
    Ambu AuraGain Laryngeal Mask
  • Manufacturer
    CARESTREAM MEDICAL ULC.

Manufacturer

CARESTREAM MEDICAL ULC.