| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-00041-1 |
| Product Name/Description |
Breath-A-Tech (Standard and Hospital Grade) Spacers
ARTG: 142303 & 214561 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/02/2020 |
| Responsible Entity |
|
| Reason/Issue |
The Instructions for Use (IFU) included with these devices has been updated with additional instructions for checking that the valve is sitting flat and for correct device assembly prior to use.
There is a risk of valve deformity or dislodgement if the devices are assembled incorrectly. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Medical Developments International is advising customers that updated IFUs will be available with new devices distributed from Jan 2020.
Existing customers are advised to retain a copy of the Customer Letter with their device IFU and take note of the following specific instructions:
· Always take care to assemble the device correctly
· Check for foreign objects and broken deteriorated parts
· Replace the Breath-A-Tech Spacer immediately if any damaged or missing parts are evident
· Never use a defective valve
· Check the valve is sitting flat and not twisted or deformed
· When fitting in the valve, ensure the 4 pegs on the Chamber are lined up with the 4 holes in the valve
· A deformed valve may indicate that the mouthpiece has been screwed on too tightly
· Visually inspect the valve and the rest of the device before and after each use
· There is a risk of the valve being dislodged if these steps aren’t always followed
This action has been closed out on 24/06/2020 |
| Contact Information |
(03) 9547 1888 - Medical Developments International |