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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
GemStar SP Infusion Suite Database, Version 1.0 		see related information
Date Posted April 15, 2011
Recall Number Z-1999-2011
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
Code Information list 13092-04-01, lot numbers 71-494-G1, 72-613-G1 and 84-832-G1
Recalling Firm/
Manufacturer		 Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Ileana Quinones
224-212-2000
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 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
 
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