RecallRadar

FDA Device recall Z-2738-2014

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

On 2014-10-08 the FDA classified a Class II recall of SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids by Baxter Healthcare, citing 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 6/3/20….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2738-2014
ClassificationClass II
Statusterminated
Initiated2014-09-03
Published2014-10-08
Last updated2026-09-13 11:53 UTC
CompanyBaxter Healthcare
Distributionn/a

Product

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

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.

Identifiers

code_info
Software Versions 5.02.06, 6.02.06, and 6.02.11; Affected Serial Numbers: 712090, 723687, 723842, 724966, 725820, 73597…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2738-2014%22

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