BEUDAMED
    FDA Recall 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 · Initiated April 24, 2014

    Recall

    Recall Number
    Z-1682-2014
    Event Number
    68124
    Firm
    Davol, Inc., Subs. C. R. Bard, Inc.
    FEI Number
    1213643
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 24, 2014
    Posted
    June 2, 2014
    Terminated
    December 23, 2015
    Address
    100 Crossings Blvd, Warwick, RI, 02886-2850

    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.

    Action

    Davol, Inc., Subs. C. R. Bard, Inc.sent an Urgent Medical Device Recall letter dated April 28, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory and quarantine product subject to the recall, contact Davol Customer Service at 1-800-556-6275 or C.R. Bard's Medical Services and Support Department at 1-800-562-0027 for instructions on how to return the product to Davol, Consignees were also instructed to complete and return the recall effectiveness check form, and notify their customers if the product was further distributed. For questions regarding this recall call 1-800-556-6275.

    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