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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 3 Recall
SIGMASpectrum 		see related information
Date Posted July 18, 2012
Recall Number Z-2030-2012
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.
Code Information All versions
Recalling Firm/
Manufacturer		 Sigma
711 Park Ave
Medina, New York 14103-1036
Consumer Instructions Contact the recalling firm for information
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.
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.
 
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