BEUDAMED
    FDA Enforcement Class II Terminated

    HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710

    Recall: Z-1032-2015 · Reported February 4, 2015

    Enforcement

    Recall Number
    Z-1032-2015
    Event ID
    70050
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2015
    Initiation Date
    December 19, 2014
    Classification Date
    January 29, 2015
    Termination Date
    January 26, 2016
    Address
    3 Corporate Dr, N/A, Lake Zurich, IL, 60047-8930, United States

    Description

    HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710

    Reason

    The lot failed pH specification.

    Code Info

    Lot 6005501, Exp. Date 1/2016

    Distribution

    Nationwide Distribution

    Quantity

    Domestic: 69,725