BEUDAMED
    FDA Recall Terminated

    Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing.

    Recall: Z-1554-2009 · Initiated April 16, 2009

    Recall

    Recall Number
    Z-1554-2009
    Event Number
    51986
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 16, 2009
    Posted
    July 15, 2009
    Terminated
    May 9, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145

    Description

    Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing.

    Reason

    When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.

    Action

    Radiometer America Inc. issued a recall notification letter dated May 5, 2009 to all customers containing information on replacement of all potentially defective waste containers and instruction on how to handle any mounted waste containers. For further questions, contact Radiometer America Inc. at 1-800-736-0600.

    Distribution

    Worldwide Distribution to US and Canada.

    Quantity

    905-590 (D512): 35,552 bottles; 905-802 (D513): 45,204 bottles