FDAClass IIIJuly 25, 2012

SIGMASpectrum Infusion Pump Master Drug Library recall: Software Issue

SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs…

Why was SIGMASpectrum Infusion Pump Master Drug Library recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All versions

Product
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs…
Recalling firm
Sigma
Quantity
2,048 CD's
Distribution
Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
Recall date
July 25, 2012
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls