| TGA Action ID |
RC-2026-RN-00833-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
EchoTip Ultra with High-Definition Ultrasound Access Needle
Lot Number: C2415199
Reference Part Number: ECHO-HD-19-A
Order Number: G52012 |
| ARTG Number |
163822 |
| Unique Device Identifier (UDI) |
(01)00827002520127(17)290401(10)C2415199 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
A product identification discrepancy has been identified for EchoTip Ultra with High-Definition Ultrasound Access Needle (ECHO-HD-19-A), lot C2415199. All five units are labelled as ECHO-HD-19-A; however, one unit contains an EchoTip ClearCore ECHO-BX-22, lot C2416756. As it cannot be determined from the labelling which unit contains the incorrect device, all five devices are being recalled as a precaution.
Potential harm associated with use of the incorrect device includes irritation or minor mucosal trauma resulting in temporary discomfort, or perforation resulting in a minor, self-limited bleed requiring medical intervention during the same procedure.
To date, Cook Medical has not received any complaints reporting harm to the patient relating to the incorrect device. |
| Instructions for Customers/Users |
Customers are to:
- Quarantine any affected product, and cease further distribution and use.
- Return affected product to Cook Medical with a signed Customer Response Form to receive a product credit |
| Action Commencement Date |
20/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 777 222 - Cook Medical |