BEUDAMED
    FDA Recall 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 · Initiated March 5, 2015

    Recall

    Recall Number
    Z-1684-2015
    Event Number
    70659
    Firm
    Codman & Shurtleff, Inc.
    FEI Number
    3002947440
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 5, 2015
    Posted
    May 28, 2015
    Terminated
    February 16, 2017
    Address
    325 Paramount Drive, Raynham, MA, 02767

    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

    Action

    Codman Neuro issued recall letter on 3/05/15 requested to immediately check all inventory to determine if you have affected product. Complete the Acknowledgement Form and follow the instructions to report your inventory status and return affected product for credit and replacement (if requested). General inquiries, customer service or field action logistics - please contact Codman Neuro Quality at: [email protected] or 866-491-0974.

    Distribution

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

    Quantity

    5463 units