BEUDAMED
    FDA Recall Terminated

    BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ Catalog #0010302, lot number HUTL1283. The BardVentralex" Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric". It is intended for use in all forms of hernia repair requiring reinforcement with a non-absorbable support material

    Recall: Z-2124-2011 · Initiated April 11, 2011

    Recall

    Recall Number
    Z-2124-2011
    Event Number
    58470
    Firm
    Davol, Inc., Sub. C. R. Bard, Inc.
    FEI Number
    1213643
    Product Code
    FTL
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    April 11, 2011
    Posted
    May 2, 2011
    Terminated
    October 27, 2011
    Address
    100 Crossings Blvd, Warwick, RI, 02886-2850

    Description

    BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ Catalog #0010302, lot number HUTL1283. The BardVentralex" Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric". It is intended for use in all forms of hernia repair requiring reinforcement with a non-absorbable support material

    Reason

    Mislabeled: Bard Medium Ventralex Hernia Patch 6.4cm /2.5" packaged in a pre-printed carton identified for a Bard Ventralex Small Circle 4.3cm /1.7"

    Action

    Davol sent an Urgent: Medical Device Recall letter on April 11, 2011, via FedeX Priority Overnight to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and remove and return the recalled lot. Distributors were requested to notify their accounts. For questions contact the Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Services & Support Department at 1-800-562-0027.

    Distribution

    Nationwide Distribution - USA including AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, MT, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV.

    Quantity

    146 units