Cook Inc. recalls VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drain…

Recall date

May 31, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2791-2018

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

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

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.