| TGA Action ID |
RC-2025-RN-00830-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
3-WAY STOPCOCK NUTRICAIR ENTERAL WITH ENFIT
Batch Numbers: 21J27-TNVX, 21L13-TNVX, 22C07-TNVCNP, 22C21-TCNP, 23G10-T, 23G22-T, 23G24-T, 23K20-T, 24F10-TDP
UDI: 13661657022995 |
| ARTG Number |
317624 |
| Unique Device Identifier (UDI) |
13661657022995 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Following several complaints, the manufacturer has identified a potential occlusion problem at the ENFit connector bonding area on the stopcock.
An occlusion at the stopcock prevents the administration of enteral nutrition via the tube. This malfunction does not present a direct risk to the patient, apart from a delay in administration. The problem is immediately resolved by replacing the defective stopcock with another functional device.
Affected batches may have been distributed to hospitals since November 2021. |
| Instructions for Customers/Users |
Customers are to:
- Immediately identify all affected lot numbers and quarantine on site to prevent further use until stock can be checked for absence of occlusion.
- Check for the absence of occlusion before connecting the stopcock, using a syringe as instructed in the Customer Letter.
- Stop using the device if occlusion is present and use another stopcock of a different batch.
This action has been finalised on 16/3/2026. |
| Action Commencement Date |
6/11/2025 |
| Responsible Entity |
|
| Contact Information |
07 3348 9155 - Midmed Customer Service |