FDAFDA · Food and drugs·Recall number Z-2030-2012
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.
Published July 25, 2012 · Recall initiated: April 23, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sigma
- Distributor
- Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
- Lot
- All versions
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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