BEUDAMED
    FDA Enforcement Class II Terminated

    Marketing brochures for the PowerPICC and PowerPICC SOLO catheters

    Recall: Z-2808-2015 · Reported September 30, 2015

    Enforcement

    Recall Number
    Z-2808-2015
    Event ID
    71757
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 30, 2015
    Initiation Date
    July 20, 2015
    Classification Date
    September 23, 2015
    Termination Date
    February 10, 2017
    Address
    605 N 5600 W, N/A, Salt Lake City, UT, 84116-3738, United States

    Description

    Marketing brochures for the PowerPICC and PowerPICC SOLO catheters

    Reason

    Bard Access Systems is recalling marketing brochures for the PowerPICC¿ and PowerPICC¿ SOLO¿ catheters due to incorrect indication for use contained in the brochure.

    Code Info

    The brochures were purchased from the vendor on 04/14/2015, Code S120667R0

    Distribution

    Distributed to domestic and foreign conference attendees.

    Quantity

    1811