BEUDAMED
    FDA Recall Terminated

    Harvard 1 Single Channel Syringe Infusion Pump, P/N 2003-001

    Recall: Z-0432-05 · Initiated November 3, 2004

    Recall

    Recall Number
    Z-0432-05
    Event Number
    30301
    Firm
    Harvard Clinical Technology
    FEI Number
    1218257
    Product Code
    MEA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 3, 2004
    Posted
    January 26, 2005
    Terminated
    May 7, 2012
    Address
    22 Pleasant Street, Natick, MA, 01760

    Description

    Harvard 1 Single Channel Syringe Infusion Pump, P/N 2003-001

    Reason

    Potential pump motor/encoder assembly failure may cause over infusing medication in patients

    Action

    Harvard Clinical Technology notified consignees by letter on 11/3/04. Harvard will contact consignees by telephone to schedule a return. The motors inside the recalled products will be replaced at Harvard Clinical. Harvard will provide Loaner pumps upon request during the repair process.

    Distribution

    AK, KY, TX, MA, NY, CA, GA, OK, IL, CT, LA, FL, MD,NC, NJ, VA, MI, WI, IA, WV,OH,

    Quantity

    154 units