| TGA Action ID |
RC-2026-RN-00119-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
16F Dual-Valved Splittable Sheath Introducer
Part Numbers: H965103028031/EU, H965103028041/EU, H965103028051/EU
Lot Numbers: I3270828, I3302439, I3302440
Expiry Dates: 31/03/2028, 30/04/2028 |
| ARTG Number |
283676 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Merit Medical Systems, Inc. is conducting a recall of the Merit 16F Dual-Valved Splittable Sheath Introducer due to a design defect. Specifically, the sheath introducer may not split as intended.
Merit has received customer complaints regarding this problem, some of which involve patient injury. Failure of the sheath introducer to split as intended may result in haemorrhage, foreign bodies, and procedure delay. |
| Instructions for Customers/Users |
Customers are to immediately discontinue use of the affected product and destroy it at point of use.
The other products included with the sheath introducer may continue to be used. |
| Action Commencement Date |
4/03/2026 |
| Responsible Entity |
|
| Contact Information |
1300 696 374 - Merit Medical Australia |