BEUDAMED
    FDA Enforcement Class II Terminated

    Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

    Recall: Z-0497-2018 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0497-2018
    Event ID
    78943
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2018
    Initiation Date
    August 24, 2017
    Classification Date
    February 1, 2018
    Termination Date
    May 1, 2020
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690, United States

    Description

    Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

    Reason

    In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.

    Code Info

    Model: 0128-0001, 0128-0025, 0128-0135, 0128-0136, and 0128-0451 Lot/Serial #'s: 1074,8305,8718, 11325, 11540, 16230, 32982, 34076, 42678, 52734, 55337, 60959, 60965, 64104, 67638, 68079, 69199, 72740, 90734, 100817, 12001289, 12001409, 12001557, 12001612, 12008230, 004325, 008303, 012348, 018148, 032159, 041927, 048278, 054171, and 069850

    Distribution

    Worldwide Distribution to the countries of : Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland

    Quantity

    77