BEUDAMED
    FDA Recall Terminated

    PALL Medical LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE. CATALOG/MODEL/Reorder Number: LGB. CLASSIFICATION NAME: Filter, Blood, Cardiopulmonary Bypass Arterial Line. COMMON/USUAL NAME: Arterial Line Filter with Bypass Loop. -- Manufactured by: PALL NEWQUAY, CORNWALL, TR9 6TT, UK -- Device Listing # D000745. --- Designed to reduce the levels of circulating leukocytes and remove microemboli greater than 40 microns in size from the perfusate during extracorporeal circulation including: gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris.

    Recall: Z-2856-2011 · Initiated May 26, 2011

    Recall

    Recall Number
    Z-2856-2011
    Event Number
    59259
    Firm
    Pall Corporation
    FEI Number
    2432733
    Product Code
    LGB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 26, 2011
    Posted
    July 21, 2011
    Terminated
    October 3, 2012
    Address
    25 Harbor Park Drive, Port Washington, NY, 11050-4605

    Description

    PALL Medical LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE. CATALOG/MODEL/Reorder Number: LGB. CLASSIFICATION NAME: Filter, Blood, Cardiopulmonary Bypass Arterial Line. COMMON/USUAL NAME: Arterial Line Filter with Bypass Loop. -- Manufactured by: PALL NEWQUAY, CORNWALL, TR9 6TT, UK -- Device Listing # D000745. --- Designed to reduce the levels of circulating leukocytes and remove microemboli greater than 40 microns in size from the perfusate during extracorporeal circulation including: gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris.

    Reason

    Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure.

    Action

    Pall Medical sent an "Important Customer Notification" letter dated May 26, 2011 to all affected customers. The letter included a description of the problem, affected lots and provided recommendations including the return of the product. For additional information, please contact the firm at (516) 484-0263.

    Distribution

    Nationwide (USA) Distribution including the states of CA, LA, MI, TX and WI.

    Quantity

    232 units