| TGA Action ID |
RC-2026-RN-00501-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Hotline Fluid Warming Set
Affected List Number: L-70
Affected Lot Numbers: 4293569, 4326087 & 4337725 |
| ARTG Number |
398170 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
ICU Medical received seven complaints involving an increased likelihood of leakage in three lots of L-70 HOTLINE Fluid Warming Sets. This problem is due to potentially inadequate solvent application at the tubing to return connector bond, with leakage occurring from an inadequate bond at this connection.
Delay of therapy may occur if a L-70 set is deemed unusable during pre-use checks, and a replacement set is not immediately available. Interruption of therapy may occur if leakage during use requires replacement of the set. Under-delivery of medication, exposure to infectious or toxic agents, and air in line, are also possible due to leakage in sets. |
| Instructions for Customers/Users |
Customers are to
- Inspect inventory and quarantine affected lots of HOTLINE Fluid Warming Sets
- Complete the Customer Response Form as instructed in the customer letter, and destroy the product in accordance with institutional procedures |
| Action Commencement Date |
1/07/2026 |
| Responsible Entity |
|
| Contact Information |
1800 654 949 - Customer Service |