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
|
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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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