Recall Z-0134-2008 ยท FRN Pump, Infusion
Smiths Medical MD, Inc.
Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software - Administrator REF 21-6275-51 RX only, Smiths Medical MD, Inc. St Paul, Minnesota 55112 USA
| Date | Feb 26, 2008 (initiated Aug 14, 2007) |
| Status | Terminated |
| Reason | Incorrect dosage possible: A software anomaly in the CADD-Sentry Pro Administrator software (version B) where the values of a weight based protocol go to zero or round up to the next higher hundredths place, even if Administrator displayed the values correctly at data entry. |
| Root cause | Software design |
| Action | A Smiths Medical MD employee visited the consignees between August 14 and 31, 2007, to verbally notify them of the recall, collect the recall CD-ROM containing the affected software and replace with the updated software. |
| Quantity | 3 CD-ROMs |
| Distribution | UT, MD, CO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062892 | EUKARE Eumed Biotechnology Co., Ltd., Jan 22, 2007 |