Z-2738-2014Class II

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

Name: Z-2738-2014 SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids
Creator: Baxter Healthcare Corp.
Published: 2014-09-03
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2014-09-03 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids on 2014-09-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2738-2014
Classification: Class II
Status: Terminated
Initiated: 2014-09-03
Posted: 2014-10-01
Terminated: 2017-03-16
Recalling firm: Baxter Healthcare Corporation
Product: SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
Product code: FRN Pump, Infusion
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2738-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2738-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30

Product code FRN

K042121Class IISpectrum and Spectrum with Master Drug LibrarySigma Intl. / cleared 2004-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)