Events

Recall of 3 WHEEL ROLLATOR WALKER WITH BASKET TRAY AND POUCH

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRIVE 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
    18760
  • Event Risk Class
    III
  • Event Initiated Date
    2016-07-21
  • 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
    Drive medical canada inc received a report of an injury associated with the deluxe 3-wheel rollator. upon a full investigation it was determined that the maintenance of all of the nuts and bolts was not followed. further investigation revealed that the user's manual did not specify this aspect for on-going use for the rollator.

Device

3 WHEEL ROLLATOR WALKER WITH BASKET TRAY AND POUCH
  • Model / Serial
    Model Catalog: 10289BL (Lot serial: 9E110400403)
  • Product Description
    DELUXE 3-WHEEL ROLLATOR
  • Manufacturer
    DRIVE MEDICAL CANADA INC.

Manufacturer

DRIVE MEDICAL CANADA INC.