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U.S. Department of Health and Human Services

Class 2 Device Recall VentriClear II Ventricular Drainage Catheter Set

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  Class 2 Device Recall VentriClear II Ventricular Drainage Catheter Set see related information
Date Initiated by Firm November 19, 2015
Date Posted December 14, 2015
Recall Status1 Terminated 3 on February 22, 2017
Recall Number Z-0416-2016
Recall Event ID 72718
510(K)Number K071640  
Product Classification Catheter, ventricular (containing antibiotic or antimicrobial agents) - Product Code NHC
Product VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Code Information Catalog Number: 50318Lot Numbers: F4365351X, F4692818X, NS5274254X, NS5667436X, NS5727900X, NS6079165X, NS6079166X
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations
812-339-2235
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 35
Distribution Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NHC and Original Applicant = COOK, INC.
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