Z-0416-2016 Class II Terminated
FDA device recall Z-0416-2016 was initiated by Cook Inc. on Nov 19, 2015 and is designated Class II. 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… The recall status is terminated (terminated Feb 22, 2017). Affected quantity: 35.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 23, 2015
- Initiation Date
- Nov 19, 2015
- Termination Date
- Feb 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35
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.
Distribution Pattern
Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.
Code Information
Catalog Number: 50318Lot Numbers: F4365351X, F4692818X, NS5274254X, NS5667436X, NS5727900X, NS6079165X, NS6079166X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0416-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026