| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-00033-1 |
| Product Name/Description |
Green Rusch Lite Disposable Metal Laryngoscope Blade
Product Code: 004551004
Lot Number: 1812341
ARTG 286313
(Teleflex Medical Australia Pty Ltd - Laryngoscope Blade, Rigid, Single Use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/01/2020 |
| Responsible Entity |
|
| Reason/Issue |
Teleflex have received 11 customer complaints reporting that the light guide of the Rusch GreenLite Mac laryngoscope broke at the point of a welded joint, either prior to use during setup or during use inside the patient's mouth. The occurrence rate associated with this failure is approximately 0.0031%.
If this product failure occurs and is not identified prior to use, the consequences may include:
1) Delay in procedure while medical personnel retrieve the broken component and potentially locate an alternative laryngoscope to reintubate and proceed with tracheal intubation;
2) If the broken component cannot be located immediately medical personnel may require diagnostic imaging to assist in the retrieval process. Additional medical intervention (e.g., a bronchoscopy) and increased patient monitoring may also be required. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately check inventory and quarantine affected stock.
Customers are advised to contact Teleflex Customer Services to organise return of affected goods. Teleflex will issue a credit note upon receipt of the returned product.
This action has been closed out on 04/01/2021 |
| Contact Information |
1300 360 226 - Teleflex Customer Service |