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-1482-06
  • 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=47912
  • 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 606051FX - LOT 13084977; CAT 606051JX - LOT 13077739; CAT 606051MX - LOT 13100828; CAT 606151FX - LOT 13095822; CAT 606151JX - LOT 13090978; CAT 606151MX - LOT 13090976; CAT 6062310F - LOT 13090973; CAT 6062310J - LOT 13090974; CAT 6062310M - LOT 13082015; CAT 6062510FX - LOT 13075472; CAT 6062510JX - LOT 13090975; CAT 6062510MX - LOT 13082020; CAT 6062511FX - LOT 13090979; CAT 6062511JX - LOT 13090971; CAT 6062511MX - LOT 13090972.
  • 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 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