GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira, Inc., Lake Forest, IL 60045; li
FDA device recall Z-1999-2011 · posted 2011-04-15 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- 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.
- 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).
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 139 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Canada, Chile, Colombia and Singapore
- Date initiated
- 2011-03-23
- Date posted
- 2011-04-15
- Date terminated
- 2016-08-29
- Location
- Lake Forest, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE (K083019) | Hospira, Inc. | 2008-10-22 |