BEUDAMED
    FDA Recall 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 · Initiated July 7, 2016

    Recall

    Recall Number
    Z-0298-2017
    Event Number
    74809
    Firm
    TZ Medical, Inc.
    FEI Number
    1000127185
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    July 7, 2016
    Terminated
    October 28, 2016
    Address
    17750 SW Upper Boones Ferry Rd, Ste 150, Portland, OR, 97224-7086

    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.

    Action

    TZ Medical notified their consignees by telephone on July 7, 2016. Customers with the boxes with the identified statement, "With Antimicrobial barrier, the firm plans to overlabel the statement on-site. If customer does not have the mis-labeled box upon contact, no action is planned. The firm also determined to overlabel devices on-hand. For questions regarding this recall call 503-639-0282.

    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)