BEUDAMED
    FDA Enforcement Class II Terminated

    3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.

    Recall: Z-2154-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2154-2012
    Event ID
    62595
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Greiner Bio-One North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    July 2, 2012
    Classification Date
    August 7, 2012
    Termination Date
    June 11, 2013
    Address
    4238 Capital Dr, Monroe, NC, 28110, United States

    Description

    3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.

    Reason

    Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.

    Code Info

    Lot #B041206

    Distribution

    Nationwide Distribution

    Quantity

    838.9 cases (1,006,700 pieces)