BEUDAMED
    FDA Recall 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 · Initiated April 27, 2015

    Recall

    Recall Number
    Z-1709-2015
    Event Number
    71175
    Firm
    MRP, LLC dba AMUSA
    FEI Number
    1000151124
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 27, 2015
    Posted
    June 4, 2015
    Terminated
    May 2, 2016
    Address
    5209 Linbar Dr, Ste 640, Nashville, TN, 37211-1026

    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

    Action

    The firm, AMUSA, sent a "Voluntary Recall Notification" dated 4/24/2015 to their consignees via Fed Ex on 04/27/2015. The letter described the product, problem and actions to be taken. The consignees were instructed to return any product remaining in the distribution channel to AMUSA; check with your product representative to determine if you have any of the listed products; if any product is located, call (615) 833-2633 from 8:30 am to 5:00 pm (Eastern Time) to receive instructions as to how to return the product; follow the enclosed Steps for Voluntary Recall in their entirety, and complete and return the enclosed Product Tracking and Verification Form. Please contact your AMUSA customer service representative if you have any questions regarding this correction, any of our products, or would like assistance with the corrections. Customers can also contact the Director, Quality Assurance at 513-325-1940 or email [email protected].

    Distribution

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

    Quantity

    200,000 units