| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00708-3 |
| Product Name/Description |
GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a GemStar battery pack)
List Numbers: 13075.1 and 13075.3 (2003 - 2006); 13075-24-03, 13075-24-05 & 13075-24-07 (2006 - 2011)
ARTG Number: 138118 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
This is an update to Hospira’s previous Safety Alert Notice (TGA Ref # RC-2011-RN-00812-3) concerning the GemStar Docking Station. At that time, Hospira had received reports from customers of sparking, smoking, charring and electrical shock when using the GemStar Docking Station. Hospira’s investigation concluded that the primary root cause was related to the potential for fluid ingress into the docking station. The design improvements have now been finalised and Hospira is replacing all existing docking stations with the new design. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers to advise Sponsor of the number of docking stations held and they will be replaced with the newly designed units. |
| Contact Information |
1300 046 774 - Hospira Customer Service |