CLASS III Device recall · Reported 25 Jul 2012 · FDA Enforcement Report
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor recalled
Sigma is recalling SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor, distributed nationwide in the US. The recall was initiated on 23 Apr 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2030-2012
- FDA event ID
- 61691
- Recalling firm
- Sigma, Medina, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Apr 2012
- FDA classified
- 18 Jul 2012
- Reported
- 25 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 23 Apr 2012 | Recall initiated by company | |
| 18 Jul 2012 | Classified by FDA | +86 days |
| 25 Jul 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
Questions about this recall
Is SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor recalled?
Yes. Sigma recalled SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor on 23 Apr 2012. The recall is Class III and its status is Terminated. Recall number Z-2030-2012.
Why was it 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.
Which lots are affected?
All versions
Where was it sold?
Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |