Company:Sigma
Date of Enforcement Report 7/25/12
Class lll:

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. Recall Number Z-2030-2012

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/MANUFACTURER
Sigma, Medina, NY on 4/23/2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2,048 CD’s

DISTRIBUTION
Nationwide and Internationally

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