BEUDAMED
    FDA Recall Terminated

    Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.

    Recall: Z-1797-2008 · Initiated April 21, 2008

    Recall

    Recall Number
    Z-1797-2008
    Event Number
    47873
    Firm
    Mentor Texas, Inc
    FEI Number
    1000118360
    Product Code
    FPK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 21, 2008
    Posted
    September 5, 2008
    Terminated
    July 29, 2010
    Address
    3041 Skyway Cir N, Irving, TX, 75038-3500

    Description

    Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.

    Reason

    During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.

    Action

    A Customer Letter was issued to all consignees by the firm on 4/21/2008. Consignees were informed that a recent testing of these products discovered a potential defect in the packaging configuration, which could result in a loss of package integrity. Consignees were asked to review inventory and dispose of product and contact firm for credit.

    Distribution

    Class II Recall - Worldwide Distribution ---- including USA, Puerto Rico and countries of Argentina, Austria, Bermuda, Brazil, Canada, China, Costa Rica, Cyprus, Denmark, England, Germany, Greece, Guatemala, India, Italy, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Morocco, Pakistan, Panama, Paraguay, Portugal, Slovak Republic, Slovenia, Spain, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turkey and Venezuela.

    Quantity

    4,321 boxes.