BEUDAMED
    FDA Enforcement Class II Terminated

    Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03

    Recall: Z-0293-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0293-2016
    Event ID
    72451
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TZ Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2015
    Initiation Date
    October 14, 2015
    Classification Date
    November 18, 2015
    Termination Date
    October 24, 2016
    Address
    17750 SW Upper Boones Ferry Rd Ste 150, N/A, Portland, OR, 97224-7086, United States

    Description

    Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03

    Reason

    The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal

    Code Info

    Lot Numbers: AGR554; AGR554\20; AGR554\24; AGR554/24; AGR570\28; AGR570/43; AGR744124; AGR744137.

    Distribution

    US nationwide distribution.

    Quantity

    32,170 units