| TGA Action ID |
RC-2025-RN-00332-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
C-MAC Video Laryngoscope Blades
Multiple product descriptions/article numbers
8403XXX series
Serial numbers: All |
| ARTG Number |
285413 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The PEEK coating on the handles of C-MAC Video Laryngoscope blades has been observed to delaminate or peel during extreme mechanical stress, prolonged wear or reprocessing. This phenomenon could expose the underlying material, potentially affecting the mechanical integrity of medical devices.
It was noted that this could result in small fragments becoming dislodged, with the potential risk of a foreign fragment entering the mouth or airway. |
| Instructions for Customers/Users |
· Customers should ensure that they read the Instructions for Use (IFU), particularly the section on visual inspection and the appropriate actions to be taken if the product has been damaged.
· Customers must indicate in the response form whether the specified serial number (SN) product is still in their possession or has been withdrawn from circulation.
This action has been finalised on 24/06/2025. |
| Action Commencement Date |
24/03/2025 |
| Responsible Entity |
|
| Contact Information |
0499 101 531 - Pat Brown, Karl Storz Endoscopy Australia |