BEUDAMED
    FDA Recall Terminated

    Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.

    Recall: Z-0586-2008 · Initiated December 19, 2007

    Recall

    Recall Number
    Z-0586-2008
    Event Number
    46317
    Firm
    Myelotec, Inc.
    FEI Number
    3000215691
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    December 19, 2007
    Posted
    April 10, 2008
    Terminated
    December 3, 2008
    Address
    4000 Northfield Way, Suite 900, Roswell, GA, 30076-4955

    Description

    Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.

    Reason

    Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.

    Action

    Consignees were first notified by phone on 12/19/2007. A follow up Urgent Label Insert Recall Notification letter was sent via certified mail on/about 12/28/2007. Consignees were instructed to remove the subject label inserts from the affected product in inventory, replace with the enclosed revised label inserts and to complete the attached Recall and Accountability Form. The incorrect label inserts were to be returned, via package provided to Myelotec.

    Distribution

    Worldwide Distribution --- USA including states of AL, CA, CT, FL, GA, ID, IN, ME, MN, NH, NJ, NY, OH, and OR, and countries of Aurba, Korea, Japan, Switzerland, South Africa, UK.

    Quantity

    1,252 shipping containers