BEUDAMED
    FDA Enforcement Class II Terminated

    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

    Recall: Z-0724-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0724-2021
    Event ID
    86986
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2020
    Initiation Date
    December 14, 2020
    Classification Date
    December 23, 2020
    Termination Date
    July 19, 2021
    Address
    1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States

    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

    Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa

    Code Info

    Lot Number: 4178253 Exp. Date: November 2019

    Distribution

    US Nationwide distribution.

    Quantity

    85 units