Recall Z-2791-2018— Cook Inc.

Name: FDA recall Z-2791-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-31

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2018-05-31, terminated 2019-04-11. It names one FDA 510(k) clearance: K011812. Product: 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.. Reason: 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)..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-31
Terminated: 2019-04-11
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K011812 — SPECTRUM VENTRICULAR CATHETERCook, Inc.·cleared 2001-11-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.