BEUDAMED
    FDA Enforcement Class II Terminated

    Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

    Recall: Z-0191-2015 · Reported November 19, 2014

    Enforcement

    Recall Number
    Z-0191-2015
    Event ID
    69464
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Davol, Inc., Subs. C. R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 19, 2014
    Initiation Date
    October 8, 2014
    Classification Date
    November 7, 2014
    Termination Date
    December 23, 2015
    Address
    100 Crossings Blvd, Warwick, RI, 02886-2850, United States

    Description

    Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

    Reason

    The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug.

    Code Info

    Lot# HUYD0176

    Distribution

    US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO.

    Quantity

    78 units