BEUDAMED
    FDA Enforcement Class II Terminated

    Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector

    Recall: Z-0715-2013 · Reported January 30, 2013

    Enforcement

    Recall Number
    Z-0715-2013
    Event ID
    63959
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medisystems a NX Stage Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 30, 2013
    Initiation Date
    December 20, 2012
    Classification Date
    January 23, 2013
    Termination Date
    October 10, 2013
    Address
    350 Merrimack St, N/A, Lawrence, MA, 01843-1748, United States

    Description

    Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector

    Reason

    Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge

    Code Info

    Lot: Number: 110914F8

    Distribution

    US Nationwide Distribution in the states of NY, PA and TN.

    Quantity

    16 cases (15 cs x 250 ea) 4,000 needles