Events

Recall of BOMIMED DISPOSABLE FIBRE OPTIC LARYNGOSCOPE HANDLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BOMIMED 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
    44724
  • Event Risk Class
    II
  • Event Initiated Date
    2017-07-13
  • 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
    Due to handles requiring batteries to operate it was determined the potential for insufficient contact causing inconsistent (intermittent or flickering) lighting was present for a small number of the handles. intermittent lighting may compromise the user's ability to visualise the patient's airway which may result in delayed treatment.

Device

BOMIMED DISPOSABLE FIBRE OPTIC LARYNGOSCOPE HANDLE
  • Model / Serial
    Model Catalog: OL-334L6 (Lot serial: 3016); Model Catalog: OL-334L6 (Lot serial: 4016); Model Catalog: OL-334L6 (Lot serial: 2216); Model Catalog: OL-334L6 (Lot serial: 4816)
  • Product Description
    Disposable Fiber Optic Medium Laryngoscope Handle
  • Manufacturer
    BOMIMED INC.

Manufacturer

BOMIMED INC.
  • Manufacturer Address
    WINNIPEG
  • Manufacturer Parent Company (2017)
    Bomimed Inc
  • Source
    HC