BEUDAMED
    FDA Recall Terminated

    Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.

    Recall: Z-0452-2009 · Initiated July 16, 2008

    Recall

    Recall Number
    Z-0452-2009
    Event Number
    50156
    Firm
    Medical Device Technologies, Inc.
    FEI Number
    1036710
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 16, 2008
    Posted
    January 6, 2009
    Terminated
    April 21, 2009
    Address
    3600 Sw 47th Ave, Gainesville, FL, 32608-7555

    Description

    Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.

    Reason

    Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.

    Action

    Each consignee was notified of recall by letter on 07/16/2008 . The letter described the problem and indicated the corrective action to be taken. A Customer Acknowledgment Form with request to fax form to firm's QA Dept was provided. Contact Medical Device Technologies, Inc., Quality Assurance Department at 1.352.338.0440, ext 350 and 353 for assistance.

    Distribution

    Nationwide - FL, TX, WI, PA, MN, SC, NC, KY, TN, CA, AR, OR, NJ, and IA.

    Quantity

    180 Units