Recalls / —
—#142021
Product
VentriClear II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
- FDA product code
- NHC — Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K071640
- Affected lot / code info
- Catalog Number: 50318Lot Numbers: F4365351X, F4692818X, NS5274254X, NS5667436X, NS5727900X, NS6079165X, NS6079166X
Why it was recalled
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 (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Cook Inc.
- Address
- 750 N Daniels Way, Bloomington, Indiana 47404-9120
Distribution
- Distribution pattern
- Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.
Timeline
- Recall initiated
- 2015-11-19
- Posted by FDA
- 2015-12-14
- Terminated
- 2017-02-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #142021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.