BEUDAMED
    FDA Enforcement Class II Terminated

    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

    Recall: Z-2476-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2476-2015
    Event ID
    71735
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MRP, LLC dba AMUSA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2015
    Initiation Date
    July 2, 2015
    Classification Date
    August 27, 2015
    Termination Date
    April 3, 2017
    Address
    5209 Linbar Dr Ste 640, N/A, Nashville, TN, 37211-1026, United States

    Description

    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

    Reason

    Procedures for the acceptance and control of in-process product have not been adequately established.

    Code Info

    KH04143,exp. 07/2016; KH04145, exp. 08/2016; KH04153, exp. 11/2016; KH04155, exp. 12/2016

    Distribution

    Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.

    Quantity

    551 cases