BEUDAMED
    FDA Recall Terminated

    Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes.

    Recall: Z-2178-2008 · Initiated December 17, 2007

    Recall

    Recall Number
    Z-2178-2008
    Event Number
    48630
    Firm
    Cook Vascular Inc.
    FEI Number
    2522007
    Product Code
    MQH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 17, 2007
    Posted
    September 16, 2008
    Terminated
    September 16, 2008
    Address
    1186 Montgomery Ln, Vandergrift, PA, 15690-6065

    Description

    Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes.

    Reason

    mislabeled - 300 micron flexipets were labeled as 80 microns

    Action

    The sales representatives were notified via email on 12/14/07 of the problem. The recalling firm issued recall letters on 12/18/07 via overnight mail. The letter informed the customers of the problem and the need to return any product. The letter also instructed customers to notify any sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance.

    Distribution

    The product was shipped to a medical facility in TN and sales reps in NJ and MD. The product was also shipped to distributors in Indonesia, Australia, and Ireland

    Quantity

    35 vials