Events

Recall of NEO-TEE (T-PIECE RESUSCITATOR)

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

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
    22023
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-02
  • 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
    Mercury medical has issued field safety notice due to the potential of a silicone mask with a 15 mm male port being able to be forcibly inserted into the protective cap covering the opening of the t-piece circuit. incorrect use of the product in this way will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient resulting in hypoxia or delay in patient care.

Device

NEO-TEE (T-PIECE RESUSCITATOR)
  • Model / Serial
    Model Catalog: M1091335VS (Lot serial: All lots); Model Catalog: M1091316VS (Lot serial: All lots); Model Catalog: M1091365VS (Lot serial: All lots)
  • Product Description
    NEO-TEE (T-PIECE RESUSCITATOR)
  • Manufacturer
    TRUDELL MEDICAL MARKETING LIMITED

Manufacturer

TRUDELL MEDICAL MARKETING LIMITED