Events

Recall of RE TURN 7500

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

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
    152702
  • Event Risk Class
    III
  • Event Initiated Date
    2014-07-28
  • 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
    During the period april 2009 to may 2011 handicare used a wing handle in which the screw and the handle after repeated tightening may slide appart. this causes a small amount of play in the attachment of the ladder which in turn results in high load at the attachment holes of ladder. eventually this may cause mechanical fatigue in the material of the ladder.

Device

RE TURN 7500
  • Model / Serial
    Model Catalog: NOT APPLICABLE (Lot serial: >10 serial no. contact manuf.)
  • Product Description
    RE TURN 7500
  • Manufacturer
    HANDICARE USA

Manufacturer

HANDICARE USA