BEUDAMED
    FDA Recall Terminated

    CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112.

    Recall: Z-1235-2010 · Initiated December 23, 2009

    Recall

    Recall Number
    Z-1235-2010
    Event Number
    54284
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    2183502
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 23, 2009
    Posted
    April 5, 2010
    Terminated
    December 10, 2011
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112.

    Reason

    The CADD-Legacy 1 Model 6400 Ambulatory Infusion Pump (Serial Number 370969) was shipped without documentation that the required accuracy testing had been performed during the manufacturing process. If the subject infusion pump did not go through the accuracy testing, and if it does not meet accuracy specifications, there is a potential for over or under-delivery.

    Action

    Smiths Medical telephoned the customer on December 23, 2009, to return the CADD-Legacy 1 Ambulatory Infusion Pump, serial number 370969, since there was no record of the completed accuracy testing for the infusion pump.

    Distribution

    MI

    Quantity

    1