Events

Recall of KLEENSPEC CORDED ILLUMINATOR

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

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
    53008
  • Event Risk Class
    II
  • Event Initiated Date
    2015-09-21
  • 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
    Welch allyn has been made aware that the kleenspec 788 corded illuminator has the potential to be incorrectly connected to a commonly available ac power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. this may result in a shattered lamp bulb and a potential electric shock hazard. commonly available ac line power cords do not have an integrated wall transformer and therefore the electrical current from the outlet is fully transferred into the device. there have been no associated injuries but the misconnection can be reproduced. for example the illuminator cord connector may fit into ac power cords from common consumer equipment such as laptop computers and other medical devices that have similar power cord connector.

Device

KLEENSPEC CORDED ILLUMINATOR
  • Model / Serial
    Model Catalog: 78810 (Lot serial: All); Model Catalog: 78800 (Lot serial: All); Model Catalog: 73410 (Lot serial: All)
  • Product Description
    KleenSpec Corded Illuminator
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED