BEUDAMED
    FDA Recall Terminated

    Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. catheter and a separately packaged catheter tray. The catheter tray and its respective accessories are manufactured in the US by Vygon. Sterilization of this catheter tray occurs via EtO by North American Sterilization and Packaging, Franklin, NJ. Labeled as Neonatal Catheter & Insertion Tray.

    Recall: Z-0850-03 · Initiated April 9, 2003

    Recall

    Recall Number
    Z-0850-03
    Event Number
    26213
    Firm
    Vygon Corporation
    FEI Number
    2245270
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 9, 2003
    Posted
    May 20, 2003
    Terminated
    October 3, 2006
    Address
    1 Madison Street, East Rutherford, NJ, 07073

    Description

    Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. catheter and a separately packaged catheter tray. The catheter tray and its respective accessories are manufactured in the US by Vygon. Sterilization of this catheter tray occurs via EtO by North American Sterilization and Packaging, Franklin, NJ. Labeled as Neonatal Catheter & Insertion Tray.

    Reason

    Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.

    Action

    Recalls letters were sent out to customers and sales representatives on 4/9/2003. They were also notified via e-mails and phone calls on 4/9/2003.

    Distribution

    Product was only distributed domestically to customers and sales representatives in MA, NY, GA, FL, OH, CO, and CA. There are no Govt. accounts.

    Quantity

    20