BEUDAMED
    FDA Recall Terminated

    SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and end caps. Capillary samplers for drawing small amounts of blood for blood gas analysis.

    Recall: Z-0975-2007 · Initiated June 22, 2006

    Recall

    Recall Number
    Z-0975-2007
    Event Number
    37526
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    GIO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 22, 2006
    Posted
    July 3, 2007
    Terminated
    May 8, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and end caps. Capillary samplers for drawing small amounts of blood for blood gas analysis.

    Reason

    The clinitubes are not able to be filled due to contamination with silicone during production.

    Action

    The firm notified their customers of this recall with a letter dated 6/22/2006. The letter informs the customers of the problem with the affected lots of SafeCLINITUBES and asks that the customers discard any remaining boxes of affected product on-site. The recall letter is accompanied by a FAX FORM (response form) which the customer is asked to complete in order to request replacement product to be sent to their individual locations.

    Distribution

    Nationwide and Canada.

    Quantity

    175 boxes