Events

Recall of KING LTSD OROPHARYNGEAL AIRWAY

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

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
    31558
  • Event Risk Class
    II
  • Event Initiated Date
    2011-01-27
  • 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
    This recall has been initiated due to product below specified hardness. the tubes are too pliable and would be difficult to use for intubation. there is a possibility that the tube could fold over in the narrower areas of assembly. supplier of lts-d products noted in their process and informed king systems on jan 21 2011.

Device

KING LTSD OROPHARYNGEAL AIRWAY
  • Model / Serial
    Model Catalog: KLTSD405 (Lot serial: KLTSD405: Lot# 201011-169)
  • Product Description
    King Systems LTS-D Airway
  • Manufacturer
    KING SYSTEMS

Manufacturer

KING SYSTEMS
  • Manufacturer Address
    NOBLESVILLE
  • Source
    HC