BEUDAMED
    FDA Recall Terminated

    CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories 82-8850 Certas Therapeutic Management System

    Recall: Z-1468-2014 · Initiated December 13, 2013

    Recall

    Recall Number
    Z-1468-2014
    Event Number
    67793
    Firm
    Codman & Shurtleff, Inc.
    FEI Number
    3002947440
    Product Code
    JXG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 13, 2013
    Posted
    April 17, 2014
    Terminated
    April 21, 2016
    Address
    325 Paramount Drive, Raynham, MA, 02767

    Description

    CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories 82-8850 Certas Therapeutic Management System

    Reason

    Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.

    Action

    Codman Neuro issued notification packages dated 12/13/13 to Domestic Hospitals and international accounts. Specific letters and associated inclusion of the additional aids, include A) a valve setting verification guide with instructions for use with x-ray images, and B) a plastic valve cut out overlay). A response reply form was included to be completed and returned to confirm effectiveness of the notification.

    Distribution

    Nationwide Distribution.

    Quantity

    9,445 units