BEUDAMED
    FDA Enforcement Class II Terminated

    CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and Stopcock for pump refills. .

    Recall: Z-1684-2015 · Reported June 3, 2015

    Enforcement

    Recall Number
    Z-1684-2015
    Event ID
    70659
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Codman & Shurtleff, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2015
    Initiation Date
    March 5, 2015
    Classification Date
    May 28, 2015
    Termination Date
    February 16, 2017
    Address
    325 Paramount Drive, Raynham, MA, 02767, United States

    Description

    CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and Stopcock for pump refills. .

    Reason

    Needle is leaking from hub/needle cannula connection

    Code Info

    Lot numbers: 14B114CT, 14E011CT, and 14E366CT

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.

    Quantity

    5463 units