VentriClear II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from
FDA device recall Z-0416-2016 · posted 2015-12-14 · Terminated
Recall details
- Recalling firm
- Cook Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NHC
- Quantity affected
- 35
- Distribution
- Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.
- Date initiated
- 2015-11-19
- Date posted
- 2015-12-14
- Date terminated
- 2017-02-22
- Location
- Bloomington, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM (K071640) | Cook, Inc. | 2007-07-12 |