Cook Inc.: Medical Device Recall in 2018 - (Recall #: Z-2791-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.

Product Classification:

Class II

Date Initiated: May 31, 2018

Date Posted: August 22, 2018

Recall Number: Z-2791-2018

Event ID: 80492

Reason for Recall:

This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS).

Status: Terminated

Product Quantity: 250

Code Information:

lot 8639185

Distribution Pattern:

One distributor in Indiana; product was not further distributed to end users.

Voluntary or Mandated:

Voluntary: Firm initiated