Recall Z-2030-2012 ยท FRN Pump, Infusion
Sigma
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.
| Date | Jul 18, 2012 (initiated Apr 23, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Sigma sent an Urgent: Customer Safety Alert dated April 23, 2012 via UPS delivery to all consignees requesting both acknowledgement of notification and confirmation that recommended actions have been taken. Customers are asked to follow the instructions contained in the recall letter. Customers with questions may contact the firm at 800-356-3454 ext 300. |
| Quantity | 2,048 CD's |
| Distribution | Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042121 | SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY Sigma Intl., Aug 26, 2004 |