| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00107-1 |
| Product Name/Description |
Disposable Analgesia Breathing Circuit 3.0m EXPANDABLE 22mmID Tubing, Filter, Hand piece with One-way Valve and Mouthpiece
Batch Number: 1272308
Part Number: MC/3200/F
Expiry Date: 04/10/2026
ARTG 413518
(Swirl Technologies Pty Ltd T/A Parker Healthcare - Breathing circuit, anaesthesia, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
Connection of the 22mmID EXPANDABLE 3.0m Length Tubing to the Analgesia Unit is tight and found to be difficult to attach to some devices.
No patient health hazard is identified once attached to Analgesia Unit; however, attachment difficulties may cause a delay in administering nitrous oxide to the patient.
This does not affect any other Parker Healthcare products. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should identify stock of affected model and batch, and quarantine immediately.
Parker Healthcare Pty Ltd will recall affect batch 1272308 and a replacement will be provided. |
| Contact Information |
03 9872 0222 - Parker Healthcare Pty Ltd |