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U.S. Department of Health and Human Services

Class 3 Device Recall SIGMASpectrum

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  Class 3 Device Recall SIGMASpectrum see related information
Date Initiated by Firm April 23, 2012
Date Posted July 18, 2012
Recall Status1 Open3, Classified
Recall Number Z-2030-2012
Recall Event ID 61691
510(K)Number K042121  
Product Classification Pump, infusion - Product Code FRN
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/
711 Park Ave
Medina NY 14103-1036
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = SIGMA INTL.