| TGA Action ID |
RC-2026-RN-00173-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Namic Rotating Adaptor Syringes and various procedure packs containing Namic Rotating Adaptor Syringes
Namic Rotating Adaptor Syringes
Product Codes: 70075027, 70083007, 70084007, 70085007 & 70087007
Various procedure packs containing Namic Rotating Adaptor Syringes
Component Codes: 80083007, 80084007, 80085007 & 80087007 |
| ARTG Number |
137395, 140057, 366766, 371886 |
| Unique Device Identifier (UDI) |
Various |
| Action Type |
Recall / Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Medline has identified a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose or fully disconnected connection between the syringe and the manifold. The investigation attributed the root cause to excess silicone migrating from the syringe barrels to the luers during the manufacturing process.
A total of 250 complaints were filed between June 2023 and February 19, 2026, associated with syringe and manifold disconnection problems. |
| Instructions for Customers/Users |
PRODUCT CORRECTION – PROCEDURE PACKS ONLY
Customers are to:
- Immediately check their stock for the affected item number(s) listed.
- Count the number of affected procedure packs but do not discard
- At the time of use, remove only the Namic Rotating Adaptor Syringe from each procedure pack and destroy it.
- Continue using the remaining items in the procedure pack.
RECALL – SINGLE STERILE ONLY
Customers are to:
- Immediately check their stock for the affected item number(s) listed.
- Quarantine then destroy the affected product according to the Customer Letter. |
| Action Commencement Date |
6/03/2026 |
| Responsible Entity |
|
| Contact Information |
1800 110 511 - Customer Service Team |