| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00803-1 |
| Product Name/Description |
McGRATH MAC video laryngoscope and EMS Video Laryngoscope
Item Codes: 300-000-000 and 300-200-000
GTIN: 15060272980020 and 15060272980112
All serial numbers prior to 366170
ARTG 191341
(Medtronic Australasia Pty Ltd - Laryngoscope, intubation) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
In July 2024, Medtronic issued an Urgent Medical Device Recall notification (RC-2024-RN-00609-1) for McGRATH MAC video laryngoscopes, which were within their useful life of 5 years (Serial numbers 366170 to 405673).
This update is to inform customers that the July 2024 notification also applies to devices beyond their 5-Year useful life (Serial numbers prior to 366170).
The battery management system within the devices being removed 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.
Next generation McGRATH MAC video laryngoscopes, item code 301-000-000, are not affected and can continue to be used for patient care. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
- Immediately discontinue use of all 300-000-000 devices (irrespective of age).
- Uninstall the battery assembly from the devices and dispose of the device and battery as per local procedures. |
| Contact Information |
0402 897410 - James Woodin, Medtronic |