BEUDAMED
    FDA Recall Terminated

    BioPince Full Core Biopsy Instrument packed in aTyvek/plastic blister pack which is labeled as previously stated and also in a cardboard shelf carton labeled as MDTECH Gainesville, Florida 32608 BioPince FULL CORE BIOPSY INSTRUMENT ga. cm REF: Lot

    Recall: Z-0952-04 · Initiated March 2, 2004

    Recall

    Recall Number
    Z-0952-04
    Event Number
    29023
    Firm
    Medical Device Technologies, Inc.
    FEI Number
    1036710
    Product Code
    GAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 2, 2004
    Posted
    July 20, 2004
    Terminated
    July 7, 2012
    Address
    3600 SW 47th Ave, Gainesville, FL, 32608-7555

    Description

    BioPince Full Core Biopsy Instrument packed in aTyvek/plastic blister pack which is labeled as previously stated and also in a cardboard shelf carton labeled as MDTECH Gainesville, Florida 32608 BioPince FULL CORE BIOPSY INSTRUMENT ga. cm REF: Lot

    Reason

    The outer plastic blister packagiing material may be cracked thereby compromising the device's sterility barrier.

    Action

    The firm mailed a recall letter to accounts on 3/2/2004 asking each account to inspect their in stock product for damage and to to notify the recalling firm and return product. Also the firm enclosed a response card in a self addressed postage paid envelope.

    Distribution

    The devices were distributed to 586 domestic medical facilites nationwide and to 13 international accounts.

    Quantity

    10,303