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Recall Observatory FDA recall evidence

Device product

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

Z-2738-2014

September 03, 2014

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 69122
Status
Terminated
Classification
Class II
Quantity
USA: 56 units, Canada: 2 units
Official record key
device-enforcement:Z-2738-2014

Official wording

Reason: 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.

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.

Distribution pattern: Worldwide Distribution -- USA and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.