| TGA Action ID |
RC-2025-RN-00634-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
IBPM Single Pole 390cm PVB
Product code: SCW-41.04.15029PVB
Lot number: 325155210
Expiry date: 03 June 2028 |
| ARTG Number |
461967 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
It has been identified that some units of the SCW-41.04.15029PVB Invasive Blood Pressure Monitoring (IBPM) Kit may exhibit intermittent or unreliable signal transmission between the pressure transducer and the patient monitor cable. In some cases, the connector requires manual pressure to establish or maintain a continuous signal trace.
If undetected or uncorrected, this may result in the loss or delay of invasive blood pressure readings during patient monitoring.
No patient injuries, harm or adverse events have been reported. |
| Instructions for Customers/Users |
Customers are to immediately quarantine any affected stock on hand to prevent for use.
Contact ITL Customer Service on 1300 188 493 to arrange for collection of affected stock.
Affected customers will be provided an Invasive Blood Pressure Monitoring Kit (Product code # LS-096) as a suitable alternative.
ITL Australia is advising that if affected stock must be used before alternate stock arrives, ensure the monitor cable and transducer connector are securely connected. Confirm that a continuous pressure trace is displayed on the patient monitor before clinical use. Be aware that any movement or loosening of the connection may result in loss of signal, which could impact patient monitoring. This is a temporary measure until alternate cables or kits are supplied.
This action has been finalised on 27/10/2025. |
| Action Commencement Date |
22/07/2025 |
| Responsible Entity |
|
| Contact Information |
1300 188 493 - ITL Customer Service Australia |