Events

Recall of DISPOSABLE NEBULIZER KIT

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
    24596
  • Event Risk Class
    II
  • Event Initiated Date
    2011-02-18
  • 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
    Components used in the production of trudell's nebulizer kits have been identified as recalled product manufactured by unomedical inc. the issue with the recalled oxygen masks is that there could be a sticky substance on the inside and/or outside of the mask that may manifest itself in approximately 6 to 8 months after manufacture of the product. the sticky masks could result in inconvenience and in some cases there is a remote possibility of potential harm to the patient.

Device

DISPOSABLE NEBULIZER KIT
  • Model / Serial
    Model Catalog: M0293776E (Lot serial: 1000783); Model Catalog: M0293776E (Lot serial: 1000860); Model Catalog: M0293777E (Lot serial: 1000800); Model Catalog: M0293777E (Lot serial: 0900742)
  • Product Description
    DISPOSABLE NEBULIZER KIT
  • Manufacturer
    TRUDELL MEDICAL MARKETING LIMITED

Manufacturer

TRUDELL MEDICAL MARKETING LIMITED