BEUDAMED
    FDA Recall Terminated

    Sodium Chloride Injection USP, manufactured by IV Flush LLC

    Recall: Z-0546-05 · Initiated January 26, 2005

    Recall

    Recall Number
    Z-0546-05
    Event Number
    31082
    Firm
    IV Flush LLC
    FEI Number
    3004978897
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 26, 2005
    Posted
    March 1, 2005
    Terminated
    September 17, 2008
    Address
    3905 Melcer, Suite 601, Rowlett, TX, 75088

    Description

    Sodium Chloride Injection USP, manufactured by IV Flush LLC

    Reason

    Device marketed without 510(k) clearance and is suspected to be contaminated with P. Flourescens.

    Action

    The firm initiated the recall by fax to distributors on 01/26/2005. On 2/16/2005 the firm faxed a second recall letter with return reciept response card to all consignees.

    Distribution

    Product was distributed nationwide.