Events

Recall of Device Recall Arterial Needles

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
    77273
  • Event Risk Class
    Class 2
  • Event Number
    Z-2252-2017
  • Event Initiated Date
    2017-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155591
  • 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
    Saw, manual and accessories - Product Code GDR
  • Reason
    Argon medical has received a complaint from one of their distributors of a potential packaging defect. the product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.
  • Action
    Argon Medical Devices, Inc. is sending an Urgent Medical Device Recall letter by registered mail to the affected customer/hospital/distributor. Customers are instructed to inspect and quarantine and return any affected product remaining at their facility utilizing the instruction on the Recall Response Form.

Device

Device Recall Arterial Needles
  • Model / Serial
    11161099 11161729 11160990 11160912
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands
  • Product Description
    Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 || Usage: || Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.
  • Manufacturer
    Argon Medical Devices, Inc

Manufacturer

Argon Medical Devices, Inc