BEUDAMED
    FDA Recall Terminated

    BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) Product code: 0112700 Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted polypropylene monofilaments. It is indicated for the repair of inguinal hernia defects

    Recall: Z-0446-2011 · Initiated October 15, 2010

    Recall

    Recall Number
    Z-0446-2011
    Event Number
    57008
    Firm
    Davol, Inc., Sub. C. R. Bard, Inc.
    FEI Number
    1213643
    Product Code
    FTL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 15, 2010
    Posted
    November 23, 2010
    Terminated
    October 27, 2011
    Address
    100 Crossings Blvd, Warwick, RI, 02886-2850

    Description

    BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) Product code: 0112700 Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted polypropylene monofilaments. It is indicated for the repair of inguinal hernia defects

    Reason

    Mislabeled: The labeled BARD Mesh Pre-shaped product code 0112700 (1.8" x 4.0"/4.5cm x 10cm), but the contents are the BARD Mesh Large Pre-shaped product code 0113700 (2.4" x 5.4"/6.0cm x 13.7cm).

    Action

    Davol issued an "URGENT MEDICAL DEVICE RECALL" letter on October 15, 2010, via Overnight Delivery to all customers. The letter describes the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory and quaratine the product; identify and notify customers they may have further distributed the product to of this recall; contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product, and complete and return the attached EFFECTIVENESS CHECK form via fax to 1-401-825-8753. If you have an questions, please contact Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Service Support Department at 1-800-562-0027.

    Distribution

    Nationwide distribution

    Quantity

    144 units