Z-1999-2011

GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira, Inc., Lake Forest...

Name: Z-1999-2011 GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira, Inc., Lake Forest...
Creator: Hospira Inc.
Published: 2011-03-23
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-03-23 / Terminated / root cause: software

FDA source

Hospira Inc. began a recall of 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... on 2011-03-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1999-2011
Status: Terminated
Initiated: 2011-03-23
Posted: 2011-04-15
Terminated: 2016-08-29
Recalling firm: Abbott Medical
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
Product code: FRN Pump, Infusion
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.
Root cause tag: software
FDA 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 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).
Quantity in commerce: 139 units
Distribution: Worldwide distribution: USA (nationwide) and countries including: Canada, Chile, Colombia and Singapore
Product codes and lots: list 13092-04-01, lot numbers 71-494-G1, 72-613-G1 and 84-832-G1

Product code FRN

K083019Class IIGemstar Sp Infusion System with Gemstar Sp Infusion Suite SoftwareHospira, Inc. / cleared 2008-10-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)