Events

Recall of SMALL PARTICLE AEROSOL GENERATOR SPAG-2 6000 SERIES MODEL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VALEANT CANADA LP/VALEANT CANADA S.E.C.

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
    105682
  • Event Risk Class
    III
  • Event Initiated Date
    2017-04-05
  • 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
    The spag-2 nebulizer may not deliver aerosolized particles within the specified size or distribution parameters. potential health consequence includes failure of the particles to reach the lower area of the respiratory tract resulting in inadequate dosing or limited treatment effectiveness. patients with respiratory distress due to concomitant pulmonary conditions may be at greater health risk or require additional medical intervention.

Device

SMALL PARTICLE AEROSOL GENERATOR SPAG-2 6000 SERIES MODEL
  • Model / Serial
    Model Catalog: 6002 (Lot serial: S/N: 337170600007)
  • Product Description
    SMALL PARTICLE AEROSOL GENERATOR MODEL SPAG-2 6000 SERIES
  • Manufacturer
    VALEANT CANADA LP/VALEANT CANADA S.E.C

Manufacturer

VALEANT CANADA LP/VALEANT CANADA S.E.C