BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0134-2008 · Initiated August 14, 2007

    Recall

    Recall Number
    Z-0134-2008
    Event Number
    44799
    Firm
    Smiths Medical MD, Inc.
    FEI Number
    2183502
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 14, 2007
    Posted
    February 26, 2008
    Terminated
    October 31, 2008
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    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

    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.

    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.

    Distribution

    UT, MD, CO

    Quantity

    3 CD-ROMs