Events

Recall of Device Recall Cordis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cordis Corporation.

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
    27138
  • Event Risk Class
    Class 3
  • Event Number
    Z-0564-04
  • Event Initiated Date
    2003-08-29
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29260
  • 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
    Forceps, General & Plastic Surgery - Product Code GEN
  • Reason
    Some devices may have an incorrect inner label which shows product # 504302l with a length of 50cm, while the outer label is correctly labeled as product # 504300l with the length of 104mm.
  • Action
    The firm initially sent Cordis representatives to visit all 21 domestic accounts the week of August 25, 2003. Follow-up Recall notificaiton Letters were sent to each account discussing the problem and informing them that a Cordis Representative has been at their location and inspected their product for misbranded devices. In 18 cases the letter stated that NO mislabeled product was found but in three other cases they were told that mislabeled product was found and recovered. These follow-up letters to the visits were sent out on August 29, 2003. A similar inspection was performed by Cordis Representatives for International Accounts and the Recall Notification was sent to the International Accounts on 8/29/2003.

Device

Device Recall Cordis
  • Model / Serial
    Lot Number 70403255
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The devices were distributed to 21 domestic hospital accounts in MI, OK, FL, TN, NY, IN, VA, NC, WI, GA, IA, NE, CA. Also product was distributed to International Distributors in the Netherlands, Canada and Mexico.
  • Product Description
    Cordis Biopsy Forceps 7F 104 cm Standard, Product Number 504300L
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 N.W. 60th Ave, Miami Lakes FL 33014
  • Source
    USFDA