Events

Recall of Device Recall Jography

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Jomed Catheters, 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
    25424
  • Event Risk Class
    Class 2
  • Event Number
    Z-0593-03
  • Event Initiated Date
    2002-11-21
  • Event Date Posted
    2003-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25805
  • 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 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 data.
  • Extra notes in the data
  • Reason
    6 fr. catheters packaged and labeled as 5 fr.
  • Action
    Consignees notified via e-mail on 11/21/2002. The consignees were instructed to contact their customers and return product to Jomed''sdistribution center in the Netherlands.

Device

Device Recall Jography
  • Model / Serial
    Lot Number 41340
  • Product Classification
    Cardiovascular Devices
  • Distribution
    There was no U.S. distribution. The product was distributed to three consignees in Germany, Hungary and Italy.
  • Product Description
    JOGRAPHY Cardiovascular Angiographic Catheter, 5F *** pigtail *** tapered with perfusion ports *** MEDI-DYNE, INC., 604 Queensbury Ave., Queensbury, New York 12804 *** Single use, sterile, disposable intravascular catheters with an atraumatic tip.
  • Manufacturer
    Jomed Catheters, Inc.

Manufacturer

Jomed Catheters, Inc.
  • Manufacturer Address
    Jomed Catheters, Inc., 604 Queensbury Avenue, Queensbury NY 12804
  • Source
    USFDA