BEUDAMED
    FDA Recall Terminated

    Iris Sample Processing SafeCrit 75mm Tubes. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.

    Recall: Z-0208-2009 · Initiated August 1, 2008

    Recall

    Recall Number
    Z-0208-2009
    Event Number
    49092
    Firm
    Drummond Scientific Co
    FEI Number
    2518153
    Product Code
    GIO
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    August 1, 2008
    Posted
    November 7, 2008
    Terminated
    December 18, 2008
    Address
    500 Parkway, Broomall, PA, 19008

    Description

    Iris Sample Processing SafeCrit 75mm Tubes. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.

    Reason

    presence of OSCS contaminant

    Action

    The recalling firm issued recall letters dated 8/1/08 via certified mail to the label owners informing them of the problem and the need to notified their customers.

    Distribution

    Nationwide Distribution --- including states of FL and MA.

    Quantity

    2000 vials