| TGA Action ID |
RC-2026-RN-00817-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Apple-Hunt Secondary Cannula Pyramidal Tip 5mm
Lot Number: 550034148
Catalogue Number: 900-800 |
| ARTG Number |
364354 |
| Unique Device Identifier (UDI) |
00888937003833 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
An investigation identified that devices from the affected lot may contain a cannula component that exceeds the intended length specification. When the device is assembled in accordance with the Instructions for Use, the pyramidal trocar tip may not extend beyond the distal end of the cannula as designed.
The potential impact of this problem is limited to user inconvenience and/or a minor delay while an alternative device is obtained.
This condition is readily detectable during the required assembly and pre-use inspection process, as the trocar tip remains enclosed within the cannula following assembly.
No reports of patient injury associated with this problem have been received. |
| Instructions for Customers/Users |
Customers are to immediately inspect inventory for the affected product and quarantine all affected stock to prevent further use.
Gytech will provide replacement stock upon receipt of a completed Customer Response form. |
| Action Commencement Date |
19/10/2026 |
| Responsible Entity |
|
| Contact Information |
03 9822 5911 - Gytech |