| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00410-1 |
| Product Name/Description |
Green light laryngoscope blade. ISO Green Standard MAC4 - Laryngoscope Blade, Rigid, Single Use
Model Number: 4604EU
Lot Number: 0004229199
Expiry Date: 15/09/2024
ARTG 272237
(Airlife Australia Holdings Pty Ltd - Laryngoscope Blade, Rigid, Single Use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
A possible risk to patients was identified where the optic fiber piece of the laryngoscope was missing or broke off. It was noticed that the light on the blade looked different.
The potential cause of the failure was identified as an incomplete operation step.
This lot has been distributed to hospitals since 29 Nov 2022.
Airlife has not received any reports of serious injury or patient harm. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Customers are to:
- Check the devices before use and discard any device that is missing the optic fiber piece, or the light does not function.
- Set up device and test it before use on the patient to ensure the device is performing as intended.
- Customers who may experience intermittent loss of power, function loss or deterioration, limited ability to intubate, any manufacturing failure, intermittent or no light source must not use the product.
- Once all stock that has been identified by the customer as missing the optic fiber piece, or where the light is not functioning is received and reconciled, Customer Service will initiate a credit for the returned stock. |
| Contact Information |
1800 519 445 - Natasha Kshetrapal |