Cook Inc.: Medical Device Recall in 2015 - (Recall #: Z-0416-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 19, 2015

Date Posted: December 23, 2015

Recall Number: Z-0416-2016

Event ID: 72718

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.

Status: Terminated

Product Quantity: 35

Code Information:

Catalog Number: 50318Lot Numbers: F4365351X, F4692818X, NS5274254X, NS5667436X, NS5727900X, NS6079165X, NS6079166X

Distribution Pattern:

Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated