BEUDAMED
    FDA Recall Terminated

    Carbomedics VT-200 Valve Tester

    Recall: Z-0738-04 · Initiated April 30, 2002

    Recall

    Recall Number
    Z-0738-04
    Event Number
    28335
    Firm
    Carbomedics, Inc
    FEI Number
    1627803
    Product Code
    DTJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 30, 2002
    Posted
    July 20, 2004
    Terminated
    March 24, 2004
    Address
    1300 E Anderson Ln, Austin, TX, 78752-1708

    Description

    Carbomedics VT-200 Valve Tester

    Reason

    Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use.

    Action

    Letters were sent to surgeons and hospital operating room supervisors in mid-May 2002 which included the following information: It is imperative that hospitals regularly and thoroughly inspect all testing instruments for indications of wear and degredation. And, CarboMedics is in the process of re-issuing suggested maintenance and sterilization guidlines.

    Distribution

    US nationwide and to the following foreign countries: Denmark, Ireland, China, Cyprus, Greece, France, UK, Protugal, Ecuador, India, Japan, Hong Kong, Italy, Sweden, Belgium, Norway, Argentina, Spain, Malta, Austria, Switzerland, Netherlands, Germany, Australia, Finland

    Quantity

    4606 units