Reported Jul 25, 2012 · Terminated
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of…
Sigma
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sigma · 711 Park Ave · Medina, NY · 14103-1036
Is this the product you have?
- SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software
- Product UsageA customized in-house library of all IV and epidural drugs, along with their safe delivery parameters
- Lot codes and dates
- All versions
- Amount recalled
- 2,048 CD's
Where it was sold
- Nationwide
- PR
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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