BEUDAMED
    FDA Enforcement Class II Terminated

    Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens

    Recall: Z-1799-2012 · Reported June 20, 2012

    Enforcement

    Recall Number
    Z-1799-2012
    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

    Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes 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 VIH-2235 -- lots 86-088-9D, 87-106-9D, 89-080-9D, 90-048-9D, 91-058-9D, 91-059-9D, 91-135-9D, 92-110-9D, 93-062-9D, 93-063-9D, 94-034-9D, 94-044-9D, 95-030-9D, 95-052-9D, 97-051-9D, 97-053-9D, 97-071-9D, and 97-083-9D.

    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.