Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software - Administrato
FDA device recall Z-0134-2008 · posted 2008-02-26 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 3 CD-ROMs
- Distribution
- UT, MD, CO
- Date initiated
- 2007-08-14
- Date posted
- 2008-02-26
- Date terminated
- 2008-10-31
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EUKARE (K062892) | Eumed Biotechnology Co., Ltd. | 2007-01-22 |