Events

Recall of Device Recall Bone Needle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Argon Medical Devices, 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
    76292
  • Event Risk Class
    Class 2
  • Event Number
    Z-1195-2017
  • Event Initiated Date
    2017-01-18
  • Event Date Posted
    2017-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152717
  • 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
    Instrument, biopsy - Product Code KNW
  • Reason
    The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
  • Action
    Argon Medical Devices, Inc. is sending an Urgent Product Recall Notice letter dated January 17, 2017, by registered mail to all affected customers. Customers were asked to determine if their inventory shows the package defect and discontinue use of the device and promptly return the affected product. For questions regarding this recall call 903-403-0749.

Device

Device Recall Bone Needle
  • Model / Serial
    lots: 11157523, 11158179, 11158180, 11159101, 11159729
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
  • Product Description
    T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN || Intended for the purpose of harvesting bone and/or bone marrow specimens
  • Manufacturer
    Argon Medical Devices, Inc

Manufacturer

Argon Medical Devices, Inc