Events

Recall of Device Recall Percutanious Cathether Introducer Set

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
    54172
  • Event Risk Class
    Class 3
  • Event Number
    Z-0764-2010
  • Event Initiated Date
    2009-01-06
  • Event Date Posted
    2010-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87802
  • 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
    Vessel Dilator for Percutaneous Catheterization - Product Code DRE
  • Reason
    One lot of percutaneous catheter introducer set contained incorrect size needle.
  • Action
    Firm notified sole consignee by an Urgent Medical Device Recall certified letter dated 1/6/2010. The letter identified the product being recalled and asked the consignee to immediately quarantine any product remaining at their facility. The recall should be conducted to the user level. Affected products at the consignee's facility and with their customers, should be returned using the instructions on the response form. The response forms are to completed and returned by fax or e-mail as indicated. Questions or the need for additional information concerning this recall should be directed to Sarah Larson at 903-677-9351 or Sarah.Larson@argonmedical.com.

Device

Device Recall Percutanious Cathether Introducer Set
  • Model / Serial
    Lot 99715418, Exp 2014-05.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- State of CA.
  • Product Description
    Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA for VNUS, 5799 Fontanus Way, San Jose CA 95138 USA; General: 408-360-7200. || For catheter exchange or placement of closed end catheters utilizing the Desilets-Hoffman technique.
  • Manufacturer
    Argon Medical Devices, Inc

Manufacturer

Argon Medical Devices, Inc