Events

Recall of LMA MAD Nasal Intranasal Mucosal Atomisation Device (used for intranasal drug delivery)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Teleflex Medical Australia Pty Ltd.

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
    RC-2016-RN-01420-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-11-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01420-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    It has been identified that lma mad nasal intranasal mucosal atomisation device may not deliver a fully atomised plume of medication. teleflex medical has received complaints that the affected batches produced a straight stream instead of an atomised spray. the failure of the device to deliver an atomised plume may impair the effectiveness of the medication with which it is used. this can lead to serious injury or death in certain emergency situations, such as where the device is used in an off-label manner for needle-free delivery of drugs for reversal of life threatening narcotic overdose, reversal of life threatening hypoglycaemia, or treatment of epileptic seizures. this delivery issue can also occur when the device is used with medications that are intended for intranasal delivery.
  • Action
    Teleflex is advising customers to immediately quarantine affected stock and not to use or distribute this stock. Teleflex will arrange for the return of stock and will issue credit for returned stock.

Device

LMA MAD Nasal Intranasal Mucosal Atomisation Device (used for intranasal drug delivery)
  • Model / Serial
    LMA MAD Nasal Intranasal Mucosal Atomisation Device (used for intranasal drug delivery)SAP/Catalogue Number: MAD300Batch Number: 160200ARTG Number: 228140
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd