Events

Recall of Device Recall Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator Pediatric, 7F,

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
    58289
  • Event Risk Class
    Class 2
  • Event Number
    Z-2086-2011
  • Event Initiated Date
    2011-03-14
  • Event Date Posted
    2011-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98937
  • 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
    kit, plastic surgery and accessories - Product Code FTN
  • Reason
    Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
  • Action
    Argon Medical Devices sent an Urgent Medical Device Recall letter dated March 14, 2011, by certified mail to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify, quarantine and return any product remaining at their facility utilizing the instruction on the 2011 Tray Recall Response Form. Customers were instructed to complete the response form included with the letter and return by fax or email as indicated as soon as possible. Customers were instructed to pass the notice on to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. For questions regarding this recall call (903) 677-9375.

Device

Device Recall Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator Pedia...
  • Model / Serial
    Lot number 99768100
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, DE, GA, HI, IL, IN, LA, MD, MN, ND, NE, NH, NJ, NY, OK, PA, SC, TX, VA, WA, and WI and the countries of Nationwide, Japan, Australia, Canada, Singapore, and the Netherlands
  • Product Description
    Part Number 496311, Lot Number 99768100 || Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters.
  • Manufacturer
    Argon Medical Devices, Inc

Manufacturer

Argon Medical Devices, Inc