Events

Recall of OXYARM - OXYPLUS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SOUTHMEDIC 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
    29634
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-20
  • 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
    On october 6 southmedic received a customer complaint in which the co2 diffuser of the etco2 mask became disconnected from the mask andfell into the patient's mouth. further inspection of the identified lot number and investigation into root cause identified the potential for loose or missing diffusers in other lots.

Device

OXYARM - OXYPLUS
  • Model / Serial
    Model Catalog: OP-2125-8 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: OP-2125-8SLM (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: OP-2125-14 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: OK-2125-8SLM (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: OK-2125-8 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: OM-2125-14SLM (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: OM-2125-8 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: OM-2125-14 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    OxyArm-OxyPlus;EtCO2 OxyMask;OxyArm- Oxykid
  • Manufacturer
    SOUTHMEDIC INC.

Manufacturer

SOUTHMEDIC INC.