| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00788-3 |
| Product Name/Description |
Keypad of Alaris LVP module (Component of a general purpose infusion pump); Module Model: 8100
Part number: TC10005926
Manufactured between: 5 October 2011 to 9 February 2012
Multiple Serial Numbers
ARTG Number: 146664 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Alaris Pump module model 8100 that contains the door assembly with keypad part number TC10005926 may be at risk of the door keypad overlap separating from the keypad assembly. When the Pump module door keypad overlay has delaminated (loose, peeled away or separated from the door assembly) this could cause a potential for fluid ingress which could lead to a keypad malfunction causing termination of infusion with alarm. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is providing work around instructions to mitigate the risk and will be replacing affected units. |
| Contact Information |
02 9624 9013 - CareFusion Regulatory Affairs |