Recall Z-1999-2011
Hospira Inc. · initiated March 23, 2011
Product
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
Codes / lots: list 13092-04-01, lot numbers 71-494-G1, 72-613-G1 and 84-832-G1
Reason for recall
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.
FDA-determined cause: Software design
Action taken
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 additional information and technical assistance, contact Hospira Advanced knowledge Center at 1-800-241-4002, option 4 (available 24 hours a day/7 days per week).
Details
- Recall number
- Z-1999-2011
- Initiated
- March 23, 2011
- Posted by FDA
- April 15, 2011
- Terminated
- August 29, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- 139 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Canada, Chile, Colombia and Singapore
- Recalling firm
- Hospira Inc., Lake Forest, IL