BEUDAMED
    FDA Enforcement Class II Terminated

    Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.

    Recall: Z-2830-2016 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2830-2016
    Event ID
    74712
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2016
    Initiation Date
    July 11, 2016
    Classification Date
    September 15, 2016
    Termination Date
    March 22, 2017
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.

    Reason

    During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.

    Code Info

    Device Listing No.: D022512. CatalogNo.: FV14218. Lot No.: P1007637, P1007638, P1007461. Exp Date: 08/01/2016.

    Distribution

    US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.

    Quantity

    274 units