Recall Z-1999-2011 ยท FRN Pump, Infusion
Hospira Inc.
GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira, Inc., Lake Forest, IL 60045; list 13092-04-01 A stand-alone PC application for administration of medications specific to the GemStar Infuser
| Date | Apr 15, 2011 (initiated Mar 23, 2011) |
| Status | Terminated |
| Reason | The software enables programming of the GemStar device for a Bolus Lower Lockout Limit outside of the hard limits entered into the GemStar SP Infusion Suite Database PC application. |
| Root cause | Software design |
| Action | The firm, Hospira, sent "URGENT DEVICE FIELD CORRECTION" letters dated March 23, 2011 to their customers on the same date. The letter described the product, problem and preventative action to be taken by the customers until the software can be upgraded. The customers were requested to contact Hospira Global Product Safety and Complaints at 1-800-441-4100 to report adverse events, and Hospira Advanced Knowledge Center at 1-800-241-4002 for technical assistance. The accounts were also requested to complete the attached Reply Form and return it to Hospira via fax at 1-262-577-6921. For additiona |
| Quantity | 139 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries including: Canada, Chile, Colombia and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083019 | GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE Hospira, Inc., Oct 22, 2008 |