| TGA Action ID |
RC-2025-RN-00460-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Cook Beacon Tip 5.0 Fr Angiographic Catheters
Multiple Part numbers, UDI, Lot numbers and GPN's |
| ARTG Number |
137861 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Cook Medical identified that devices from the affected lots may experience tip separation. This could occur prior to use or during patient contact.
Potential adverse events that may occur if an affected product is used include harms associated with device fragmentation/separation and vessel injury. |
| Instructions for Customers/Users |
Customers are to:
- Quarantine any affected products and return them to Cook Medical with a signed copy of the Response and Receipt Form to receive a product credit.
- Immediately report adverse events to Cook Medical Customer Relations and to the TGA using the Incident Reporting Form available on the TGA website.
Unaffected devices will continue to be accessible on the market for purchase based on availability.
This action has been finalised on 17/4/2026. |
| Action Commencement Date |
9/05/2025 |
| Responsible Entity |
|
| Contact Information |
1800 777 222 - Cook Medical Customer Relations |