| TGA Action ID |
RC-2025-RN-00651-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
TUTA nPulse Connector
Product Code: 50.252P
Lot Numbers: 199555KS, 200356KS, 202425KS |
| ARTG Number |
235965 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
ICU Medical Australia has identified that certain lots of nPulse connectors may contain a smaller internal diameter than expected in the female luer lock connector.
A reduced diameter may result in difficulty when connecting a male luer connector, potentially impeding the establishment of a fluid path through the device. This could lead to delays in therapy, posing a risk of serious injury or death in critically ill patients.
At this time, ICU Medical Australia has not received any reports of injury associated with this problem. |
| Instructions for Customers/Users |
Customers are to:
· Check all inventory locations within their facility for the affected product lots listed in the notification, discontinue use, and quarantine any affected stock to prevent further use.
· Contact the ICU Medical Australia Customer Service Team to arrange replacement stock, as alternate unaffected lots are available.
· Share this notification with all potential users of the device to ensure awareness. If the devices are used at another location, please ensure this communication is forwarded accordingly. |
| Action Commencement Date |
29/07/2025 |
| Responsible Entity |
|
| Contact Information |
1300 428 652 - ICU Medical Customer Service |