| TGA Action ID |
RC-2026-RN-00518-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
St Neonatal PICC Pack and St Paediatric Angiography Pack
St Neonatal PICC Pack
Product Code: 37-701
Batch Numbers: 061293026, 06729625, 06480325
St Paediatric Angiography Pack
Product Code: 38-768
Batch Numbers: 061415726, 06858825, 061044425, 061133526, 06362825, 06621525, 061567626 |
| ARTG Number |
163168 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
The packs contain the item “Stopcock - 3 Way Lipid Resistant (Yellow) – item code: MMD IV110011” that is cracking or leaking when being used with propofol.
Cracking or leaking stopcocks could cause a sudden, unmonitored drop in the infusion rate or dosage. This could lead to unexpected patient awareness under anaesthesia or inadequate sedation. Cracks could create a breach in the closed sterile system, increasing the risk of catheter-related bloodstream infections. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock and immediately quarantine any units of the affected batches to prevent further use.
- Return stock on hand with the completed response form to the sponsor.
- Contact their sale representative to arrange for a replacement/credit.
This action has been closed out on 25/08/2026 |
| Action Commencement Date |
9/07/2026 |
| Responsible Entity |
|
| Contact Information |
02 8718 2888 - Multigate Medical Products |