| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01097-1 |
| Product Name/Description |
SECUFILL patient lines X50
Batch Number: LX221001
Expiry date: 07/03/2025
Product Code: SECU002
ARTG: 282115
(Guerbet Australia Pty Ltd - Radiographic procedure tubing) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
Due to the potential for burr particulate formation and subsequent intravascular injection, the manufacturer has decided to recall identified batches of SecuFill patient lines.
The particulates originate from the protective cap used in the assembly of the device. During internal controls performed some of these particulates have been observed on the Luer-lock of some units.
There have been no reported customer complaints received in Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
1) Immediately discontinue use of the identified affected batch.
2) Check inventory and quarantine all units from the affected batch.
3) Inform all end-users of this product are made aware of this recall action.
4) Upon receipt of customer acknowledgement forms Guerbet will contact customers to arrange for the affected stock to be returned.
5) Ensure relevant staff members are informed of this recall, including relevant clinicians, and any organisations/ facilities that have been supplied any potentially affected product. |
| Contact Information |
0402 897 386 - Emma Dodd - Product Manager |