BEUDAMED
    FDA Enforcement Class II Terminated

    Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL

    Recall: Z-1946-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1946-2014
    Event ID
    68592
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ORIGIO, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 9, 2014
    Initiation Date
    June 20, 2014
    Classification Date
    June 30, 2014
    Termination Date
    July 20, 2015
    Address
    2400 Hunters Way, Charlottesville, VA, 22911-7930, United States

    Description

    Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL

    Reason

    Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration

    Code Info

    CODE: Model #s: PP-5.75-90, PP-9-90, PP-5.75-90PL, PP-9-90PL. Lots with labeled expiry date of May 2, 2015, or later.

    Distribution

    Worldwide Distribution: US Nationwide, Canada, Australia, Barbados, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Great Britain, Greece, India, Italy, Japan, Jordan, Malaysia, Netherlands, Peru, Russia, Singapore, South Africa, Spain, Taiwan, Turkey, and United Arab Emirates.

    Quantity

    Total number of Boxes Distributed 32,760. US 4,093 / Canada 1,156 / EU & Other 27,511