| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00292-1 |
| Product Name/Description |
PCA LifeCare Infusion System
Catalogue number: 0F7822703
Number on pump: 0F782
ARTG number: 138109 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in serious injury. This issue is caused by wear and tear on the Half Nut which prevents it from properly detecting the pressure build-up associated with a distal occlusion. |
| Recall Action |
Recall |
| Recall Action Instructions |
Hospira is recalling the affected pumps. The pumps have not been supplied since 2006. |
| Contact Information |
1300 046 774 (Option 1) - Hospira Customer Service |