BEUDAMED
    FDA Recall Terminated

    Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes.

    Recall: Z-2177-2008 · Initiated March 2, 2008

    Recall

    Recall Number
    Z-2177-2008
    Event Number
    48629
    Firm
    Cook Vascular Inc.
    FEI Number
    2522007
    Product Code
    MQH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 2, 2008
    Posted
    September 18, 2008
    Terminated
    September 18, 2008
    Address
    1186 Montgomery Ln, Vandergrift, PA, 15690-6065

    Description

    Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes.

    Reason

    mislabeled - 300 micron flexipets labeled as 130 micron and vice versa

    Action

    The recalling firm issued an Urgent product Recall letter on 3/3/08. The letter informed the customers of the problem and that the pouch is correctly labeled. Customers were instructed to return product and notify any sub accounts. Please contact Cook Vascular at 1-724-845-8621 for assistance.

    Distribution

    The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI.

    Quantity

    120 boxes