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U.S. Department of Health and Human Services

Class 2 Device Recall GemStar SP Infusion Suite Database, Version 1.0

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 Class 2 Recall
GemStar SP Infusion Suite Database, Version 1.0
see related information
Date Posted April 15, 2011
Recall Status1 Open
Recall Number Z-1999-2011
Recall Event ID 58202
Premarket Notification
510(K) Number
K083019 
Product Classification Pump, Infusion - Product Code FRN
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
Manufacturer 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 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.
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