BEUDAMED
    FDA Recall Terminated

    Model #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution), Waste Tubing used on ABL 7xx and ABL8xx, component of the ABL700/800 Blood Gas Analyzers, also included in service kits part no. 905-671

    Recall: Z-1260-06 · Initiated May 22, 2006

    Recall

    Recall Number
    Z-1260-06
    Event Number
    35695
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 22, 2006
    Posted
    July 26, 2006
    Terminated
    April 17, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    Model #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution), Waste Tubing used on ABL 7xx and ABL8xx, component of the ABL700/800 Blood Gas Analyzers, also included in service kits part no. 905-671

    Reason

    An increased failure rate was observed with the yellow rubber tubing. The tubing was found to be leaking blood and solutions after distribution.

    Action

    The recalling firm issued a letter to their customers dated 5/22/2006. The letter informs the customer(s) of the tubing defect and provides the customer with one (1) tubing to deal with any immediate needs which they may have. Should the customer require additional waste pump tubing replacements, the letter is accompanied by a FAX FORM which can be used to request any amount of additional replacement tubing required. The letter also shows tthe address to which the replacement tubing is to be delivered, and provides a Purchase Order request to be used, if required.

    Distribution

    Nationwide to user/customers in the U.S. and in Canada

    Quantity

    2500 Units in U.S. & 76 Units in Canada