Events

Recall of LMA MADOMIZER

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

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
    108208
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-31
  • 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
    Teleflex is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. this may result in inadequate topical anesthesia which may lead to some discomfort further attempts to deliver topical anesthesia or the use of alternative methods of anesthesia.

Device

LMA MADOMIZER
  • Model / Serial
    Model Catalog: MAD510 (Lot serial: >10 lot # contact Mfg); Model Catalog: MAD500 (Lot serial: >10 lot # contact Mfg); Model Catalog: MAD600 (Lot serial: >10 lot # contact Mfg); Model Catalog: MAD700 (Lot serial: >10 lot # contact Mfg); Model Catalog: MAD720 (Lot serial: >10 lot # contact Mfg)
  • Product Description
    LMA Mucosal Atomization Devices
  • Manufacturer
    TELEFLEX MEDICAL

Manufacturer

TELEFLEX MEDICAL