Events

Recall of GARDIAN ENVOY ROLLING WALKER MECHANICAL WALKER

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

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
    68822
  • Event Risk Class
    II
  • Event Initiated Date
    2008-06-05
  • 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
    Bolt becomes too loose with use of the walker and potentially strips the threads of the bolt and or falls out of the fork. this can cause the fork to become separated from the frame of the walker.

Device

GARDIAN ENVOY ROLLING WALKER MECHANICAL WALKER
  • Model / Serial
    Model Catalog: 07890TB (Lot serial: FROM 0308 TO 0711); Model Catalog: 07876B (Lot serial: FROM 0308 TO 0711); Model Catalog: 07886B/RD/G (Lot serial: FROM 0308 TO 0711); Model Catalog: 07887B/R (Lot serial: FROM 0308 TO 0711); Model Catalog: 07889T (Lot serial: FROM 0308 TO 0711)
  • Product Description
    rolling walkers (rollators)
  • Manufacturer
    SUNRISE MEDICAL CANADA INC.

Manufacturer

SUNRISE MEDICAL CANADA INC.