BEUDAMED
    FDA Enforcement Class II Terminated

    Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

    Recall: Z-1804-2012 · Reported June 20, 2012

    Enforcement

    Recall Number
    Z-1804-2012
    Event ID
    61945
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vygon Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2012
    Initiation Date
    May 11, 2012
    Classification Date
    June 13, 2012
    Termination Date
    March 11, 2013
    Address
    103 A Park Drive, Montgomeryville, PA, 18936-9613, United States

    Description

    Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

    Reason

    Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

    Code Info

    Product Code AMS-8280CP-4 -- lots 10K16, 10L20, 11A78, 11B24, 11B16, 11C70, and 11D14.

    Distribution

    Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.