Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of...
FDA Recall #Z-0725-2021 — Class II — December 14, 2020
Product Description
Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087
Reason for Recall
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Recalling Firm
Integra LifeSciences Corp. — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
17 units
Distribution
US Nationwide distribution.
Code Information
Lot Number:4178257 Exp. Date: November 2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated