Events

Recall of VENACURE EVLT NEVERTOUCH - FRS PROCEDURE KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ANGIODYNAMICS 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
    88305
  • Event Risk Class
    I
  • Event Initiated Date
    2011-11-25
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The hemostasis sidearm assemblies have the potential for flash to exist on the housing at the base of the threads. this flash has the potential to break off and relocate within the fluid path. if the flash found at the base of the housing of the hemostasis valve were to break off and enter the fluid path of the product it could potentially be flushed into the patient's venous system. this condition would not be obvious to the end user.

Device

VENACURE EVLT NEVERTOUCH - FRS PROCEDURE KIT
  • Model / Serial
    Model Catalog: 11403002 (Lot serial: 549609); Model Catalog: 11403002 (Lot serial: 552939); Model Catalog: 11403001 (Lot serial: 552939); Model Catalog: 11403001 (Lot serial: 549607); Model Catalog: 11403001 (Lot serial: 549609); Model Catalog: 11403002 (Lot serial: 549607)
  • Product Classification
    General and Plastic Surgery Devices
  • Product Description
    VenaCureEVLT NeverTouch Procedure Kits
  • Manufacturer
    ANGIODYNAMICS INC.

Manufacturer

ANGIODYNAMICS INC.
  • Manufacturer Address
    QUEENSBURY
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    HC