| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00705-3 |
| Product Name/Description |
Portapres NiMh battery pack (Device to continuously measure blood pressure)
Batch number: 12 02 010, 12 02 011, 12 02 003
ARTG: 138530 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
Due to a production error the battery packs may become hot and start leaking when exposed to mechanical stress.
This recall action was not notified to the TGA before it was initiated by Ptronik. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is providing work around instructions and replacing all affected battery packs. |
| Contact Information |
02 4578 9611 - Ptronik Regulatory Affairs |