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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 Terminated 3 on July 05, 2018
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/
Manufacturer		 Sigma
711 Park Ave
Medina NY 14103-1036
For Additional Information Contact
585-798-3901
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = SIGMA INTL.
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