| TGA Action ID |
RC-2025-RN-00998-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Flexor Check-Flo Introducers and Sets, Ring Transjugular Intrahepatic Access Sets, and Rosch-Uchida Transjugular Liver Access Sets
Multiple part numbers, lot numbers and UDI's |
| ARTG Number |
137911, 294463 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly. |
| Instructions for Customers/Users |
Customers should
1. Examine inventory immediately to determine if they have affected product(s) from the affected lots. If so, quarantine any affected products that remain unused. Immediately cease all further distribution and use of the affected products.
2. Return the affected product(s) to Cook Medical with a signed copy of the Acknowledgement and Receipt Form to receive a product credit.
This action has been closed out on 09/06/2026 |
| Action Commencement Date |
25/11/2025 |
| Responsible Entity |
|
| Contact Information |
1800 777 222 - Cook Medical Customer Relations |