Events

Recall of Device Recall Neptune Plus (Hemostatic Pad)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by TZ Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74809
  • Event Risk Class
    Class 2
  • Event Number
    Z-0298-2017
  • Event Initiated Date
    2016-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148503
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dressing, wound, drug - Product Code FRO
  • 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.

Device

Device Recall Neptune Plus (Hemostatic Pad)
  • Model / Serial
    Lot R970249
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AL, CA, FL, GA, IL, IN, KY, MO, MS, NC, NV, NY, PA, SC, TN, TX, and WV.
  • Product 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
  • Manufacturer
    TZ Medical, Inc.

Manufacturer

TZ Medical, Inc.
  • Manufacturer Address
    TZ Medical, Inc., 17750 SW Upper Boones Ferry Rd Ste 150, Portland OR 97224-7086
  • Manufacturer Parent Company (2017)
    Tz Medical Inc.
  • Source
    USFDA