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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 Device Recall GemStar SP Infusion Suite Database, Version 1.0see related information
Date Initiated by FirmMarch 23, 2011
Date PostedApril 15, 2011
Recall Status1 Terminated 3 on August 29, 2016
Recall NumberZ-1999-2011
Recall Event ID 58202
510(K)NumberK083019 
Product Classification Pump, infusion - Product Code FRN
ProductGemStar 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 IL 60045-2579
For Additional Information ContactMs. 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		Software design
ActionThe 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 Commerce139 units
DistributionWorldwide distribution: USA (nationwide) and countries including: Canada, Chile, Colombia and Singapore
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRN
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