BEUDAMED
    FDA Enforcement Class II Terminated

    T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.

    Recall: Z-1808-2015 · Reported June 24, 2015

    Enforcement

    Recall Number
    Z-1808-2015
    Event ID
    70974
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MRP, LLC dba AMUSA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    June 24, 2015
    Initiation Date
    February 9, 2015
    Classification Date
    June 15, 2015
    Termination Date
    June 22, 2015
    Address
    5209 Linbar Dr Ste 640, Nashville, TN, 37211-1026, United States

    Description

    T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.

    Reason

    Incorrect labeling of the expiration date

    Code Info

    KH04090

    Distribution

    US distribution to CA only.

    Quantity

    1,080 units (3 cases)