BEUDAMED
    FDA Recall Terminated

    Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React, Pulmonic Valve Conduit, NR4000-PA-C'** **'Shelhigh, Inc., 650 Liberty Ave., Union, NJ 07083 USA'** **'Shelhigh Porcine Pulmonic Valve Conduit Prosthesis Model NR-4000 Series with 'No-React' treatment*, INSTRUCTIONS FOR USE'**.

    Recall: Z-0678-06 · Initiated January 18, 2006

    Recall

    Recall Number
    Z-0678-06
    Event Number
    34692
    Firm
    Shelhigh, Inc.
    FEI Number
    1000081147
    Product Code
    MWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 18, 2006
    Posted
    March 25, 2006
    Terminated
    May 23, 2007
    Address
    650 Liberty Ave, Union, NJ, 07083-8130

    Description

    Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React, Pulmonic Valve Conduit, NR4000-PA-C'** **'Shelhigh, Inc., 650 Liberty Ave., Union, NJ 07083 USA'** **'Shelhigh Porcine Pulmonic Valve Conduit Prosthesis Model NR-4000 Series with 'No-React' treatment*, INSTRUCTIONS FOR USE'**.

    Reason

    Unapproved Device-Distribution of an unapproved device into interstate commerce.

    Action

    The firm retrieved the 6 devices from the consignees identified, following a telephone request on 1/18/2006. The firm does not consider this a recall.

    Distribution

    The devices were supplied directly to hospital and Shelhigh sales reps. There are two main accounts: Children's Hopsital of Boston, MA and Products for Surgery, Scottsdale, AZ (Shelhigh authorized salesman). The firm subsequently shipped a recalled unit, S/N PE20677 on 11/8/2005 to a European Distributor, Bioplan SRL, Parma, Italy. There are no Govt. accounts.

    Quantity

    25 units