Recall Z-3107-2011 ยท FRN Pump, Infusion
Hospira Inc.
GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use with GemStar Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; List Numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-24-01, 13075-24-03, 13075-24-05 and 13075-24-07, Note: list numbers with xxxxx-04-xx are for U.S., Canada, Japan, Netherlands and Singapore, while those with xxxxx-24-xx are f
| Date | Aug 31, 2011 (initiated Aug 1, 2011) |
| Status | Terminated |
| Reason | Hospira has received reports of sparking, smoking, charring and electrical shock when using the GemStar Docking Station due to fluid ingress into the docking station. |
| Root cause | Device Design |
| Action | Hospira Inc. sent an "URGENT DEVICE FIELD CORRECTION" letter dated August 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The requests that customers do not hang or place fluid containers over the docking station, not spray fluid directly on the docking station, and to clean the docking station using a cloth dampened with an apporoved cleaning solution. A reply form was attached to the letter for customers to complete and return via fax at 262-577-6921. Contact Hospira at 1-800-441-4100 for questions concerning thi |
| Quantity | 18,000 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Japan, Jordan, the Netherlands, Portugal, Saudi Arabia, Singapore, Spain, Sweden and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042980 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE Hospira, Inc., Nov 17, 2004 |