Events

Recall of OXYTOTE OXYGEN REGULATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDIGAS MANITOBA 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
    15917
  • Event Risk Class
    I
  • Event Initiated Date
    2015-06-16
  • 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
    Mfr (western) decided to initiate this recall based on reports of ignition events involving oxytote valve integrated pressure regulators (viprs) and subsequent investigations into those events. based on the investigations western became aware of the possibility of ignition and rupture of the compressed gas oxygen cylinder which can cause serious injury and/or death.

Device

OXYTOTE OXYGEN REGULATOR
  • Model / Serial
    Model Catalog: MNR-600 (Lot serial: > 100 Numbers contact mfg); Model Catalog: MNS-603 (Lot serial: > 100 Numbers contact mfg); Model Catalog: MTR-500 (Lot serial: > 100 Numbers contact mfg); Model Catalog: MTR-700 (Lot serial: > 100 Numbers contact mfg); Model Catalog: MTS-501 (Lot serial: > 100 Numbers contact mfg); Model Catalog: MTS-502 (Lot serial: > 100 Numbers contact mfg); Model Catalog: MTS-503 (Lot serial: > 100 Numbers contact mfg)
  • Product Classification
    Anesthesiology Devices
  • Product Description
    OXYTOTE OXYGEN REGULATOR
  • Manufacturer
    MEDIGAS MANITOBA LTD

Manufacturer

MEDIGAS MANITOBA LTD