Z-0416-2016Class II

VentriClear II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid...

Name: Z-0416-2016 VentriClear II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid...
Creator: Cook Inc.
Published: 2015-11-19
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2015-11-19 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of VentriClear II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain on 2015-11-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0416-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-19
Posted: 2015-12-14
Terminated: 2017-02-22
Recalling firm: Cook Incorporated
Product: VentriClear II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Product code: NHC Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected].
Quantity in commerce: 35
Distribution: Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.
Product codes and lots: Catalog Number: 50318Lot Numbers: F4365351X, F4692818X, NS5274254X, NS5667436X, NS5727900X, NS6079165X, NS6079166X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0416-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0416-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-14

Product code NHC

K071640Class IIVentriclear II, Spectrum Ventricular Drainage Catheter, Model N-Vvdc-02-AbrmCook, Inc. / cleared 2007-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)