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U.S. Department of Health and Human Services

Class 1 Device Recall SIGMA SPECTRUM Volumetric Infusion Pump

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 Class 1 Recall
SIGMA SPECTRUM Volumetric Infusion Pump
see related information
Date Posted April 25, 2014
Recall Status1 Open
Recall Number Z-1484-2014
Recall Event ID 67523
Premarket Notification
510(K) Number
K042121 
Product Classification Pump, Infusion - Product Code FRN
Product SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
Code Information Product Codes: 35700BAX, 35700ABB
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield, Illinois 60015-4625
Manufacturer Reason
for Recall
Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action On February 7, 2014, Baxter Healthcare Corporation distributed Urgent Device Correction notices and Customer Reply Forms to their customers via first-class mail. Affected customers are instructed to contact Baxter Healthcare Corporation at 1-800-356-3454 (choose option 1) Monday through Friday during the hours of 7:00 am to 7:00 pm Eastern Time. Baxter technicians would determine if an adjustment or repair is necessary. Customers are asked to complete the attached Customer Reply Form and return it to Baxter either by faxing to 1-224-270-5457 or e-mailing a scanned copy to fca@baxter.com.
Quantity in Commerce 277,096 units (revised)
Distribution Worldwide Distribution - USA Nationwide including PR and the country of Canada.
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 = SIGMA INTL.
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