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U.S. Department of Health and Human Services

Class 2 Device Recall SPECTRUM Pump

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  Class 2 Device Recall SPECTRUM Pump see related information
Date Initiated by Firm September 03, 2014
Date Posted October 01, 2014
Recall Status1 Terminated 3 on March 16, 2017
Recall Number Z-2738-2014
Recall Event ID 69122
510(K)Number K042121  
Product Classification Pump, infusion - Product Code FRN
Product SPECTRUM Pump, Model No. 35700BAX.

Intended to be used for the controlled administration of intravenous fluids.
Code Information Software Versions 5.02.06, 6.02.06, and 6.02.11; Affected Serial Numbers: 712090, 723687, 723842, 724966, 725820, 735977, 751130, 752124, 755174, 768538, 771990, 774743, 781406, 783736, 784698, 794466, 805797, 808901, 809113, 812462, 815932, 842120, 857926, 858672, 862085, 863721, 865630, 873459, 889597, 890260, 903748, 912619, 920574, 920589, 956346, 957394, 965402, 966684, 976931, 977550, 978361, 983979, 984066, 984129, 984475, 985946, 987538, 993445, 995291, 996014, 996389, 1013037, 1004377, 1014565, 1014962, 967887, 950671, and 938428.
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
25212 W. Illinois Route 120
Round Lake IL 60073-9799
Manufacturer Reason
for Recall		 One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.
FDA Determined
Cause 2		 Equipment maintenance
Action Initial notification was initiated via telephone call by the Baxter Medina Service Center on 8/28/14 to all affected Sigma SPECTRUM Infusion Pump consignees. URGENT DEVICE CORRECTION Letters (dated 9/03/2014) were sent to the consignees via USPS first class mail on 9/03/14 formally informing them of the recall. The letters identified the affected product, the description of the issue, the hazard involved, as well as, the actions to be taken by customer. Customers are being instructed to immediately remove the pump from use and return the pump to Baxter for inspection. The firm will provide replacements. Customers are to contact Baxter Healthcare Medina at 800-356-3454 for technical questions regarding the letter.
Quantity in Commerce USA: 56 units, Canada: 2 units
Distribution Worldwide Distribution -- USA and Canada.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FRN and Original Applicant = SIGMA INTL.
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