| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00609-1 |
| Product Name/Description |
McGRATH MAC video laryngoscope
Item Codes 300-000-000
Serial Numbers: 366170 to 405673
GTIN: 15060272980020
ARTG 191341
(Medtronic Australasia Pty Ltd - Laryngoscope, intubation) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic is recalling McGRATH MAC video laryngoscopes, item code 300-000-000, serial numbers from 366170 to 405673.
There is also an Addendum to the Instructions for Use (IFU) for item code 301-000-000.
The battery management system within the devices being removed (McGRATH MAC Video Laryngoscope device, item code 300-000-000) is not sufficient to mitigate against depletion of the battery voltage below the design threshold.
Batteries that are depleted below the design threshold may increase the risk of the battery becoming unstable, which may lead to a thermal event followed by a risk of explosion.
For customers of Next-Generation McGRATH MAC video laryngoscope devices, item code 301-000-000, this notice provides recommendations for good battery handling practices. |
| Recall Action |
Recall |
| Recall Action Instructions |
Recall:
- Immediately discontinue use of the devices being removed (300-000-000).
- Uninstall and dispose of the battery assembly from the devices being removed.
- Return the device (300-000-000) to Medtronic.
Product Defect Correction:
- Customers may continue using Next-Generation McGRATH Video Laryngoscopes Next-Generation (301-000-000)
- Follow Important Battery Handling Information stated in the IFU and addendum
- Do not use device past the 'Use By' date
- Refer to IFU for proper battery storage conditions
- Do not use a battery assembly, installed or uninstalled that has been dropped |
| Contact Information |
0402 897 410 - James Woodin |