BEUDAMED
    FDA Enforcement Class II Terminated

    Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy

    Recall: Z-0298-2017 · Reported November 2, 2016

    Enforcement

    Recall Number
    Z-0298-2017
    Event ID
    74809
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TZ Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 2, 2016
    Initiation Date
    July 7, 2016
    Classification Date
    October 21, 2016
    Termination Date
    October 28, 2016
    Address
    17750 SW Upper Boones Ferry Rd Ste 150, Portland, OR, 97224-7086, United States

    Description

    Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy

    Reason

    Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label.

    Code Info

    Lot R970249

    Distribution

    Nationwide Distribution to AL, CA, FL, GA, IL, IN, KY, MO, MS, NC, NV, NY, PA, SC, TN, TX, and WV.

    Quantity

    1410 (141 boxes of 10)