Events

Recall of ADULT VOLUME VENTILATOR CIRCUITS

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
    129005
  • Event Risk Class
    II
  • Event Initiated Date
    2014-01-03
  • 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
    Certain vital signs breathing circuits may be provided with 15mm blue port caps as a loose component and/or 22mm blue port caps attached to certain circuit ports. they are not intended to be part of the final circuit assembly. if the circuit assembly is used with the cap in place it will cause occlusion of gas flow. occlusion of gas flow can result in varying degrees of hypoxia which may be severe.

Device

ADULT VOLUME VENTILATOR CIRCUITS
  • Model / Serial
    Model Catalog: 1552016 (Lot serial: ALL LOTS); Model Catalog: 155200EU (Lot serial: ALL LOTS); Model Catalog: 1574723 (Lot serial: ALL LOTS); Model Catalog: 156205 (Lot serial: ALL LOTS); Model Catalog: 1553402 (Lot serial: ALL LOTS); Model Catalog: 156310 (Lot serial: ALL LOTS); Model Catalog: 1574710 (Lot serial: ALL LOTS); Model Catalog: 155518 (Lot serial: ALL LOTS)
  • Product Description
    ADULT VOLUME VENTILATOR CIRCUITS
  • Manufacturer
    TRUDELL MEDICAL MARKETING LIMITED

Manufacturer

TRUDELL MEDICAL MARKETING LIMITED