Recall Z-0416-2016— Cook Inc.

Name: FDA recall Z-0416-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-19

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2015-11-19, terminated 2017-02-22. It names one FDA 510(k) clearance: K071640. Product: VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.. 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..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-19
Terminated: 2017-02-22
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K071640 — VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRMCook, Inc.·cleared 2007-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.