Z-2030-2012Class III

SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software

Name: Z-2030-2012 SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software
Creator: Sigma
Published: 2012-04-23
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2012-04-23 / Terminated / root cause: software

FDA source

Sigma began a recall of SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with... on 2012-04-23. FDA classified it as Class III and gives the reason as "Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2030-2012
Classification: Class III
Status: Terminated
Initiated: 2012-04-23
Posted: 2012-07-18
Terminated: 2018-07-05
Recalling firm: Baxter Healthcare Corporation
Product: SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
Product code: FRN Pump, Infusion
Reason for recall: Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices.
Root cause tag: software
FDA root cause: Software design
Action: Sigma sent an Urgent: Customer Safety Alert dated April 23, 2012 via UPS delivery to all consignees requesting both acknowledgement of notification and confirmation that recommended actions have been taken. Customers are asked to follow the instructions contained in the recall letter. Customers with questions may contact the firm at 800-356-3454 ext 300.
Quantity in commerce: 2,048 CD's
Distribution: Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
Product codes and lots: All versions

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2030-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2030-2012	Class III	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)