BEUDAMED
    FDA Recall Terminated

    IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagnostics, Inc. 2400 Hunter's Way Charlottesville, VA 22911***

    Recall: Z-1220-2007 · Initiated May 8, 2007

    Recall

    Recall Number
    Z-1220-2007
    Event Number
    38348
    Firm
    Humagen Fertility Diagnostics, Inc.
    FEI Number
    1216677
    Product Code
    MQK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 8, 2007
    Posted
    September 18, 2007
    Terminated
    October 29, 2007
    Address
    2400 Hunters Way, Charlottesville, VA, 22911-7930

    Description

    IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagnostics, Inc. 2400 Hunter's Way Charlottesville, VA 22911***

    Reason

    Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

    Action

    The recalling firm notified consignees by phone and e-mail on 05/07/07. International consignees were advised to discard product for replacement.

    Distribution

    The recalled product was distributed to 2 direct accounts in IL and to 6 international distributors in United Kingdom, Greece, Australia, United Arab Emirates, the Netherlands, and Israel.

    Quantity

    160 boxes