Events

Recall of Cordis Continuous Flush Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cordis Neurovascular, 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
    36077
  • Event Risk Class
    Class 2
  • Event Number
    Z-1483-06
  • Event Initiated Date
    2006-08-11
  • Event Date Posted
    2006-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47919
  • 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
    Continuous Flush Catheter - Product Code KRA
  • Reason
    Sterility (package integrity) compromised-cordis neurovascular, inc. discovered, during internal testing, that some catheters within the affected lots of cnv preshaped prowler and pre-shaped prowler select infusion catheters may have a pinhole or tear in the mylar pouch, which may result in a compromise of the sterility inside the pouch.
  • Action
    All consignees were notified by letter on 8/14/06. All Cordis Neurovascular sales representatives will also participate, to ensure expedited communication.

Device

Cordis Continuous Flush Catheter
  • Model / Serial
    All lot numbers equal to or lower than: CAT 606S152FX - LOT 13009595; CAT 606S152JX - LOT 13010913; CAT 606S152MX - LOT 13009596; CAT 606S155FX - LOT 13082017; CAT 606S155JX - LOT 13078245; CAT 606S155MX - LOT 13082016; CAT 606S252FX - LOT 13064387; CAT 606S252JX - LOT 13071036; CAT 606S252MX - LOT 13090990; CAT 606S255FX - LOT 13084973; CAT 606S255JX - LOT 13084974; CAT 606S255MX - LOT 13064409
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide distribution --- including USA and countries of Asia Pacific, Europe, Latin America, Canada, Japan and Australia.
  • Product Description
    Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.
  • Manufacturer
    Cordis Neurovascular, Inc.

Manufacturer

Cordis Neurovascular, Inc.
  • Manufacturer Address
    Cordis Neurovascular, Inc., 14200 NW 57th Ct, Miami Lakes FL 33014-3105
  • Source
    USFDA