BEUDAMED
    FDA Recall Terminated

    CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812

    Recall: Z-2701-2011 · Initiated March 21, 2011

    Recall

    Recall Number
    Z-2701-2011
    Event Number
    58145
    Firm
    Codman & Shurtleff, Inc.
    FEI Number
    3002947440
    Product Code
    NJE
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    March 21, 2011
    Posted
    June 29, 2011
    Terminated
    February 17, 2016
    Address
    325 Paramount Drive, Raynham, MA, 02767

    Description

    CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812

    Reason

    Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length.

    Action

    Codman & Shurtleff, Inc.sent an "Urgent Medical Device Correction Notice" on March 21, 2011. The letter recommend the incorrect label be removed and discarded. There are 3 additional peel-off labels, 2 on the outer box and one on the pouch. All 3 of these contain the correct printed size information (28 mm) that can be used for applying to the inventory sheet, patient record or patient card, as needed. It is NOT required to return any of this product to Codman. Customer Service at 1-800-225-0460 or contact your local Codman Neurovascular Representative

    Distribution

    Worldwide - Nationwide (USA), Canada, Korea.

    Quantity

    380 units