BEUDAMED
    FDA Recall 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 · Initiated March 23, 2012

    Recall

    Recall Number
    Z-0623-2013
    Event Number
    63862
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 23, 2012
    Posted
    December 31, 2012
    Terminated
    February 2, 2015
    Address
    901 Marcon Boulevard, Allentown, PA, 18109-9512

    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.

    Action

    B. Braun Medical, Inc sent an Urgent Medical Device letter dated March 23, 2012 , to all affected customers. The letter identified the product the problem and the action needed by the customer to take. B. Braun has implemented an improvement to the pump locking mechanism of t he older style pole clamps and will be upgrading any older style pole clamps that may remain within your facility. Please return the completed form from attachment 1 in the self-addressed envelope provided or fax the form to (610) 849-1197 within two (2) weeks of receipt\. If you require any additional information or have any questions, comments or concerns please contact your B. Braun Medical Customer Service at 800-627-7867.

    Distribution

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

    Quantity

    13,078