Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment ...
FDA Recall #Z-0724-2021 — Class II — December 14, 2020
Product Description
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073
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
85 units
Distribution
US Nationwide distribution.
Code Information
Lot Number: 4178253 Exp. Date: November 2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated