| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00937-1 |
| Product Name/Description |
Omrix Pressure Regulator (Surgical air pipeline regulator)
Product Codes: EVRC68 and EVR54C
ARTG Number: 203072 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
Omrix Biopharmaceuticals has identified that there may be Pressure Regulators in the field with an incorrect connector type. A Nitrous Oxide connector has been supplied instead of a Carbon Dioxide connector (SIS-CO2 connector). The connector has a different colour (Grey and not green-grey, as should be according to the Australian Standard- AS 2896- for Medical gas systems ) and in addition, instead of CARBON DIOXIDE, it was engraved with “NITROUS OXIDE’’. Johnson & Johnson Medical Pty Limited (JJM) is recalling Omrix Pressure Regulators. The nitrous oxide inlet connector is not compatible with carbon dioxide source connector and can therefore not connect to Omrix Pressure Regulator. |
| Recall Action |
Recall |
| Recall Action Instructions |
Johnson & Johnson Medical Pty Limited is requesting the customers to quarantine the affected pressure regulators. Arrangements will be made for a courier to pick up the affected product and a credit note issued. This action has been closed-out on 22/03/2016. |
| Contact Information |
1800 338 160 - JJM Customer Service |