Events

Recall of Device Recall VentriClear II Ventricular Drainage Catheter Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook 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
    72718
  • Event Risk Class
    Class 2
  • Event Number
    Z-0416-2016
  • Event Initiated Date
    2015-11-19
  • Event Date Posted
    2015-12-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142021
  • 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, ventricular (containing antibiotic or antimicrobial agents) - Product Code NHC
  • Reason
    Cook medical initiated a voluntary recall of specific lot numbers of the ventriclear ii ventricular drainage catheter set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling.
  • Action
    Cook Medical issued letter via certified mail on 11/19/2015, for their voluntary recall of the VentriClear¿ II Ventricular Drainage Catheter Set due to being sterilized twice. The Distributor was instructed to forward the recall letter on to its customers, and quarantine any unused recalled devices, and return them to Cook Medical. Customers with questions may contact: Cook Medical Customer Relations 1-800-457-4500 or 1-812-339-2235. Monday through Friday between 7:30a.m. and 5:00p.m. Eastern Daylight Time or email at CustomerRelationsNA@cookmedical.com.

Device

Device Recall VentriClear II Ventricular Drainage Catheter Set
  • Model / Serial
    Catalog Number: 50318Lot Numbers: F4365351X, F4692818X, NS5274254X, NS5667436X, NS5727900X, NS6079165X, NS6079166X
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.
  • Product Description
    VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Manufacturer Address
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA