Z-1693-2017Class II

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2

Name: Z-1693-2017 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Creator: Baxter Healthcare Corporation
Published: 2017-01-26
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2017-01-26 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2 on 2017-01-26. FDA classified it as Class II and gives the reason as "SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under...". 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-1693-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-26
Posted: 2017-10-02
Terminated: 2018-05-24
Recalling firm: Baxter Healthcare Corporation
Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Product code: FRN Pump, Infusion
Reason for recall: SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under conditions in which a message is being written to the Spectrum Infusion Pumps Event History Log (EHL), and the length of that message exactly matches the size of the available memory at the end of a memory sector. For this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the EHL.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: URGENT MEDICAL DEVICE CORRECTION Letters and Reply Forms (dated 1/26/2017) were mailed to customers via USPS first-class mail on 1/26/2017 providing the necessary instructions to customers. For questions, please contact your Baxter sales representative, or Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm ET.
Quantity in commerce: Domestic: 14,175 units; Canada: 187 units
Distribution: Natiowide, Puerto Rico and Canada
Product codes and lots: 14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1693-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1693-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-29

Product code FRN

K133801Class IIBaxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation / cleared 2014-05-07

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)