| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01420-1 |
| Product Name/Description |
LMA MAD Nasal Intranasal Mucosal Atomisation Device (used for intranasal drug delivery)
SAP/Catalogue Number: MAD300
Batch Number: 160200
ARTG Number: 228140 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall |
| Recall Action Instructions |
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. |
| Contact Information |
1300 360 226 - Teleflex Medical Australia Customer Service |