Events

Recall of Device Recall Introducer guide

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
    29574
  • Event Risk Class
    Class 3
  • Event Number
    Z-0588-05
  • Event Initiated Date
    2004-05-05
  • Event Date Posted
    2005-03-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34142
  • 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, Percutaneous - Product Code DQY
  • Reason
    The product is labeled as straight catheter but the package contains contralateral guide shaped catheters.
  • Action
    A recall letter dated 04/30/2004 was sent to the consignees, instructing them to discontinue using the product and informed them that a Cordis representive would remove any unit in their possesion.

Device

Device Recall Introducer guide
  • Model / Serial
    Lot # L0104244
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in FL, OK, SC, and KS in the US. Internationaly to South Africa and the Netherlands.
  • Product Description
    Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 NW 60th Ave, Miami Lakes FL 33014-2802
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA