Events

Recall of Device Recall VNUS ClosureFAST

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by VNUS Medical Technologies 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
    38381
  • Event Risk Class
    Class 2
  • Event Number
    Z-0132-2008
  • Event Initiated Date
    2007-03-06
  • Event Date Posted
    2007-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53511
  • 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
    Catheter - Product Code GEI
  • Reason
    Sterility (package integrity) compromised: product sterility may be compromised due to a pinhole under the pouch foldover.
  • Action
    The recalling firm has issued customer notification letters by mail on 03/06/2007. The firm is requesting that consignees discontinue their use of the device and return recalled product . The firm will provide replacements.

Device

Device Recall VNUS ClosureFAST
  • Model / Serial
    Lot Numbers: 269431 and 269157
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: Product was distributed to 18 health care providers and medical centers throughout the US in the following states: TX, UT, CA, CT, MI, NY, MI, OR, WA, VA, PA, and NJ.
  • Product Description
    VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138
  • Manufacturer
    VNUS Medical Technologies Inc

Manufacturer

VNUS Medical Technologies Inc
  • Manufacturer Address
    VNUS Medical Technologies Inc, 5799 Fontanoso Way, San Jose CA 95138
  • Source
    USFDA