| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00292-1 |
| Product Name/Description |
Tri-Staple 2.0 Black Reinforced Intelligent Reload
Model number: SIGTRSB60AXT
Lot number: N3G1372Y
Kit: K402BA LAP SLEEVE WITH SONI 7 ACCESS
ANZ Kits: 0012019505, 0012021440, 0012023720, 0012025989
CFN number: K402BA
GTIN number: 00763000179038
ARTG's 350110, 324060 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic received a complaint for “partial firing" on a Tri-Staple 2.0. Investigation identified damage to the cartridge caused by an incorrect assembly station equipment adjustment.
The problem described started at the beginning of the lot production due to a set of circumstances specific to this lot.
If the damage is present, poor staple formation and/or incomplete staple line may result, causing patient harm. No related complaints have been reported in Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should immediately identify, quarantine, then return all unused affected product within their possession. |
| Contact Information |
02 9857 9000 - David Brammy |