BEUDAMED
    FDA Enforcement Class II Terminated

    0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.

    Recall: Z-1709-2015 · Reported June 10, 2015

    Enforcement

    Recall Number
    Z-1709-2015
    Event ID
    71175
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MRP, LLC dba AMUSA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2015
    Initiation Date
    April 27, 2015
    Classification Date
    June 4, 2015
    Termination Date
    May 2, 2016
    Address
    5209 Linbar Dr Ste 640, N/A, Nashville, TN, 37211-1026, United States

    Description

    0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.

    Reason

    Incorrect expiration date on label

    Code Info

    CODES: KH04103, KH04104, KH04105

    Distribution

    US Distribution in states of:OH, PA, AL, IL, TN, and CT.

    Quantity

    200,000 units