BEUDAMED
    FDA Recall 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 · Initiated June 20, 2014

    Recall

    Recall Number
    Z-1946-2014
    Event Number
    68592
    Firm
    ORIGIO, Inc
    FEI Number
    1216677
    Product Code
    MQK
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    June 20, 2014
    Posted
    June 30, 2014
    Terminated
    July 20, 2015
    Address
    2400 Hunters Way, Charlottesville, VA, 22911-7930

    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

    Action

    Field Safety Corrective Action / Urgent Product Recall letter dated June, 2014.

    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