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Z-2738-2014 Class II Terminated

Recalled by Baxter Healthcare Corp. — Round Lake, IL

FDA device recall Z-2738-2014 was initiated by Baxter Healthcare Corp. on Sep 3, 2014 and is designated Class II. 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. The recall status is terminated (terminated Mar 16, 2017). Affected quantity: USA: 56 units, Canada: 2 units.

Recall Details

Product Type: Devices
Report Date: Oct 8, 2014
Initiation Date: Sep 3, 2014
Termination Date: Mar 16, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: USA: 56 units, Canada: 2 units

Product Description

SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.

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.

Distribution Pattern

Worldwide Distribution -- USA and Canada.

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.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2738-2014
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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