Events

Recall of MACINTOSH FIBER OPTIC LARYNGOSCOPE DISPOSABLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HEINE OPTOTECHNIK GMBH & CO. KG.

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
    65036
  • Event Risk Class
    III
  • Event Initiated Date
    2010-07-28
  • 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
    There is a tolerance issue on a certain production batch from april 2010. the result is that the heel of the blade may be too wide to be inserted into the head of laryngoscope handles manufactured to the "green standard".

Device

MACINTOSH FIBER OPTIC LARYNGOSCOPE DISPOSABLE
  • Model / Serial
    Model Catalog: F-000.22.763 (Lot serial: 62117)
  • Product Description
    XP Laryngoscope Blabe Mac 3
  • Manufacturer
    HEINE OPTOTECHNIK GMBH & CO. KG

Manufacturer

HEINE OPTOTECHNIK GMBH & CO. KG