Recall Z-2030-2012— Sigma

Name: FDA recall Z-2030-2012
Creator: U.S. Food and Drug Administration
Published: 2012-04-23

Class III · Terminated

Class III FDA medical device recall by Sigma, initiated 2012-04-23, terminated 2018-07-05. It names one FDA 510(k) clearance: K042121. 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.. Reason: 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..

Recalling firm: Sigma
Classification: Class III
Status: Terminated
Initiated: 2012-04-23
Terminated: 2018-07-05
Firm location: Medina, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K042121 — SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARYSigma Intl.·cleared 2004-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.