BEUDAMED
    FDA Enforcement Class II Terminated

    Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.

    Recall: Z-0714-2013 · Reported January 30, 2013

    Enforcement

    Recall Number
    Z-0714-2013
    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 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.

    Reason

    A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".

    Code Info

    Lot: 120719F4

    Distribution

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

    Quantity

    26 casesx 250 needles (6500needles)