Events

Recall of CLICK STYLE GAS REGULATORS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AMVEX CANADA.

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
    105831
  • Event Risk Class
    II
  • Event Initiated Date
    2012-04-24
  • 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
    Customer complained that a bang noise was heard when turning on an oxygen cylinder equipped with an amvex click-style gas regulator (complainant in ireland). there was no report of injury or damage to property. the investigation determined that a bang noise may be heard if the cylinder valve is turned on too quickly or if the sealing gasket is worn or damaged. there were three complaints related to worn seals in the past three years in addition to this reported incident although in none of the other situations was there any report of a noise. these three complaints were all from canada.

Device

CLICK STYLE GAS REGULATORS
  • Model / Serial
    Model Catalog: GR(X)X-YYY(Z)(W)-(X)(Y)(Z)(W) (Lot serial: n/a)
  • Product Description
    CLICK STYLE GAS REGULATORS
  • Manufacturer
    AMVEX CANADA

Manufacturer

AMVEX CANADA
  • Manufacturer Address
    RICHMOND HILL
  • Source
    HC