Z-2030-2012 Class III Terminated
FDA device recall Z-2030-2012 was initiated by Sigma on April 23, 2012 and is designated Class III. 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 represe… The recall status is terminated (terminated July 5, 2018). Affected quantity: 2,048 CD's.
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2012
- Initiation Date
- April 23, 2012
- Termination Date
- July 5, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,048 CD's
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
Code Information
All versions