BEUDAMED
    FDA Recall Terminated

    Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.

    Recall: Z-1878-2008 · Initiated May 6, 2008

    Recall

    Recall Number
    Z-1878-2008
    Event Number
    48623
    Firm
    Medical Device Technologies, Inc.
    FEI Number
    1036710
    Product Code
    GAA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 6, 2008
    Posted
    September 25, 2008
    Terminated
    November 10, 2011
    Address
    3600 SW 47th Ave, Gainesville, FL, 32608-7555

    Description

    Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.

    Reason

    The sterility of the product cannot be guaranteed.

    Action

    The firm sent a letter to its consignees on 5/6/08, informing of the recall and requesting that they complete and return by fax the attached customer acknowledgement form. For assistance, contact Medical Device Technologies, Inc., dba Angiotech at 1-352-338-0440 ext. 350 or ext. 353.

    Distribution

    Nationwide and to Mexico.

    Quantity

    490 units.