BEUDAMED
    FDA Enforcement Class II Terminated

    Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    Recall: Z-1682-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1682-2014
    Event ID
    68124
    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
    June 11, 2014
    Initiation Date
    April 24, 2014
    Classification Date
    June 2, 2014
    Termination Date
    December 23, 2015
    Address
    100 Crossings Blvd, Warwick, RI, 02886-2850, United States

    Description

    Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    Reason

    Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

    Code Info

    HUXH0294, HUXL0314

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM