| TGA Action ID |
RC-2025-RN-00911-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Nutricia Flocare Infinity III enteral feeding pump AC plug Head
Batch Numbers: KRDD32M, KRDD387, KRDD412, KRDD3BL, LYID43D, LYID42N, LYID43D, LYID459, LYID46T, LYID48D
Multiple batch, serial and UDI numbers |
| ARTG Number |
119667 |
| Unique Device Identifier (UDI) |
Plug head - N/A |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
Nutricia has received an internal report indicating that the AC plug heads on up to 10 batches of Flocare Infinity III pump chargers may be susceptible to breakage or disconnection when subjected to axial force, resulting in potentially unsafe conditions and faulty plug performance.
No adverse events have been reported to date in Australia. |
| Instructions for Customers/Users |
Customers are to
- Immediately inspect the AC plug heads of affected batch numbers
- Isolate any AC plug heads that are loose, broken, or damaged to prevent further use and request a replacement.
- Continue using pumps with an alternative Infinity charger or resume use once the damaged plug head has been replaced.
- Continue to follow Instructions for Proper Handling of the Flocare Infinity III Plug Head. |
| Action Commencement Date |
4/11/2025 |
| Responsible Entity |
|
| Contact Information |
1800 060 051 - Nutricia Australia |