Type of Product |
Medical Device |
TGA Recall Reference |
RC-2012-RN-01257-1 |
Product Name/Description |
Belmont Instrument Corporation Rapid Infuser (high flow, warming infusion pump).
Model Number: FMS2000
ARTG Number: 94269 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
14/12/2012 |
Responsible Entity |
|
Reason/Issue |
In the rare event of a fluid spill, salt could build up at the power entry area and may result in the remote possibility of an electrical flash occurring. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Medtel Australia is providing work around instructions and is implementing a fix to correct the issue. |
Contact Information |
03 8564 0806 - Medtel Regulatory Affairs |