BEUDAMED
    FDA Recall Terminated

    Iris Sample Processing SafeCrit 40mm Tubes. Catalog number 59-000869-002 H. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.

    Recall: Z-0209-2009 · Initiated August 1, 2008

    Recall

    Recall Number
    Z-0209-2009
    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 40mm Tubes. Catalog number 59-000869-002 H. 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

    4000 vials