Z-1451-2015Class II

Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion...

Name: Z-1451-2015 Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion...
Creator: Baxter Healthcare Corp
Published: 2015-03-02
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2015-03-02 / Terminated

FDA source

Baxter Healthcare Corp began a recall of Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The... on 2015-03-02. FDA classified it as Class II and gives the reason as "Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1451-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-02
Posted: 2015-04-16
Terminated: 2018-05-22
Recalling firm: Baxter Healthcare Corporation
Product: Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
Product code: FRN Pump, Infusion
Reason for recall: Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). The pump will administer drugs as configured. The discrepancy may cause therapy delay or unintended rate of delivery.
FDA root cause: Under Investigation by firm
Action: The firm, Baxter, sent an "Urgent Device Correction" letter dated 3/05/2015 with MDL Instructions were sent to all affected users via USPS First Class Mail on 3/05/2015. All four (4) limited launch locations with Master Drug Library (MDL) version 8.0 with SIGMA Spectrum Infusion System version 8.0 were notified via phone call on 3/02/2015. The letter describes the product, problem and actions to be taken. Baxter is requesting customers take the following actions: 1. Follow the steps described in Attachment 1 to confirm that this discrepancy is properly corrected. 2. Complete the enclosed customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to [email protected]. --- Baxter sent a follow-up Communication Letter (dated 3/17/2015) to the initial Urgent Device Correction Letter (dated 3/5/2015) to provide additional clarification and instructions to ensure continued mitigation of this discrepancy as users implement the Spectrum infusion System in their facility. The four launch sites received the follow-up letters via hand delivery; remaining customers received the follow-up letter via hand delivery and/or e-mail. If you have additional questions, please contact your Baxter sales representative, Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, during the hours of 7:00 am to 7:00 pm Eastern Time, or The Center for One Baxter at 800-422-9837, Monday through Friday during the hours of 8:00 am to 5:00 pm Central Time.
Quantity in commerce: 58 MDLs
Distribution: Worldwide Distribution: US Distribution to states of: CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, including Puerto Rico and country of: Canada.
Product codes and lots: Software version 8.0, Product Code 35723V080

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1451-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1451-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-22	2015-04-16

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)