| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01086-1 |
| Product Name/Description |
MANUJET III With Jet Vent Cath
Model: 30-01-003
Multiple Batch numbers
ARTG 129230
(Medtronic Australasia Pty Ltd - Ventilator, jet, manual) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has been notified by VBM, the manufacturer of the Manujet Ill of reports of air leakage from a scale on the Manujet III.
Soldering on the affected pressure cell had not been carried out correctly and the diaphragm had been partially detached from the base plate. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to quarantine the affected products, and return to Medtronic. To receive a credit, customers are to complete the acknowledgement form indicating the quantity of affected product. |
| Contact Information |
0436 369 694 - Jensen Webster |