| TGA Action ID |
RC-2026-RN-00495-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Microbore Extension Sets and Lipid-Resistant Stop Cocks with Extension Sets (15 cm and 25 cm DEHP-Free)
Product Codes: IV050030, IV050140, IV050180, IV110002 & IV110003
All lots/batches
Stopcock - 3 Way Lipid Resistant (Yellow)
Product Code: IV110011
All lots/batches |
| ARTG Number |
324222, 354371 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
There have been reports of the products cracking or leaking when being used with propofol. This might result in the following problems:
• Cracks and leaks in the stopcock can cause a sudden, unmonitored drop in the infusion rate and unintended dosage drops. This can lead to unexpected patient awareness under anaesthesia or inadequate sedation.
• Cracks can create a breach in the closed sterile system increasing the risk of catheter-related bloodstream infections or sepsis. |
| Instructions for Customers/Users |
Customers are to:
- Inspect stock on hand and immediately quarantine all batches to prevent further use.
- Return stock on hand with the completed Customer Response Form to the sponsor.
- Contact the local sale representative to arrange for a credit.
This action has been closed out on 28/10/2026 |
| Action Commencement Date |
10/07/2026 |
| Responsible Entity |
|
| Contact Information |
02 8718 2800 - Multigate Medical Devices |