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
This recall has been terminated (originally issued February 26, 2008).
- Company
- Smiths Medical Md, Inc.
- Recall Initiated
- August 14, 2007
- Posted
- February 26, 2008
- Terminated
- October 31, 2008
- Recall Number
- Z-0134-2008
- Quantity
- 3 CD-ROMs
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
Distribution
UT, MD, CO
Lot / Code Info
Catalog Number: 21-6275-51, Software Version B.
Root Cause
Software design
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.
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