BEUDAMED
    FDA Enforcement Class III Terminated

    0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.

    Recall: Z-2394-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2394-2012
    Event ID
    63105
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amsino Medical USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 26, 2012
    Initiation Date
    August 15, 2012
    Classification Date
    September 15, 2012
    Termination Date
    August 13, 2013
    Address
    5209 Linbar Dr, Suite 640, Nashville, TN, 37211-1026, United States

    Description

    0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.

    Reason

    One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.

    Code Info

    KH03752

    Distribution

    Distributed to one customer in Illinois.

    Quantity

    unknown