BEUDAMED
    FDA Enforcement Class II Terminated

    Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.

    Recall: Z-0623-2013 · Reported January 9, 2013

    Enforcement

    Recall Number
    Z-0623-2013
    Event ID
    63862
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 9, 2013
    Initiation Date
    March 23, 2012
    Classification Date
    December 31, 2012
    Termination Date
    February 2, 2015
    Address
    901 Marcon Boulevard, N/A, Allentown, PA, 18109-9512, United States

    Description

    Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.

    Reason

    Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.

    Code Info

    Model number 8713130 and lot numbers 209, 309, 409, 509, 809, 909, 60939747, 60943679, 60945966, 60948966, 60959578, 60960830, 60962412, 61170378, 5048020067, 5048805107, 5048920117, 5049152127, 5049484028, 5049545028, 5049614028, 5049704038, 5049788048, 5049821048, 5050123058, 5050297068, 5050385078, 5051802039, 5051879039, 5051893059, 5051940049, 5051999049, 5052519099, 5052638099, 5052690109, 5052692109, 5052711109, 5052726119, 5052788119, 5052920119, 5053045129, 5053112010, 5053129129, 5053146010, 5053207010, 5053269020, 5053449020, 5053505030, 5053534040, 5053584030, 5053605040, and 5053645040.

    Distribution

    Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.

    Quantity

    13,078