FDA-Device2018-08-22Class II
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.
Cook Inc.
Hazard
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).
Sold states
One distributor in Indiana; product was not further distributed to end users.
Affected count
250
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2791-2018Don't want to check this manually?
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