| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00863-1 |
| Product Name/Description |
Oxygen / Nitrous Oxide Circuit
Multiple Part Numbers, Lots Numbers and Expiry Dates
ARTG 210997
(Flexicare Australia Pty Ltd - Breathing circuit, anaesthesia, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
Flexicare Medical Ltd has become aware of a potential problem that may arise from the disconnection of a component from the NRV valve which could enter a patient’s airway, if during use the circuit becomes detached and is subsequently reconnected.
A design correction has been implemented between the T-piece and the circuit components; Flexicare Medical Ltd is recalling product manufactured prior to this implementation. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to quarantine devices from the affected lots. Once quarantined these are to be returned with the customer acknowledgement form. Upon receipt, Flexicare Medical Ltd will issue replacement or credit to customers. |
| Contact Information |
0450 977 007 - Kenny Ho, Flexicare Medical |