| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00152-1 |
| Product Name/Description |
GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps)
List Numbers: 13000 and 13150
ARTG Number: 138109 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Through customer complaints, Hospira has become aware that in the GemStar (Phase 3) infusion pumps, the connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the “self-test” while powering up which will result in a Beeper Error. This Beeper Error will display on the device with a service error code “Code 10/001/000”. This Beeper Error (service code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised that there is no need to return their GemStar Phase 3 Infusion pumps at this time. If a Beeper Error occurs during power up, customers are asked to remove the device from service immediately and contact Hospira to arrange for a loan pump. |
| Contact Information |
1300 046 774 (Option 1) - Hospira Customer Service |