BEUDAMED
    FDA Recall Terminated

    SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143

    Recall: Z-1111-2017 · Initiated December 14, 2016

    Recall

    Recall Number
    Z-1111-2017
    Event Number
    75978
    Firm
    Organ Recovery Systems, Inc.
    FEI Number
    3004068499
    Product Code
    KDL
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    December 14, 2016
    Terminated
    August 14, 2019
    Address
    1 Pierce Pl, Ste 475, Itasca, IL, 60143-1253

    Description

    SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143

    Reason

    Organ preservation fluid recalled due to potential for bacterial contamination.

    Action

    Firm initiated a voluntary removal of Lot PBR-0060-392 on December 14, 2016. and Lot PBR-0074-330 December 16, 2016. Notification occurred via e-mail to each recipient of the lots. On December 18, 2016, the firm provided subsequent posting notice and FAQs on company website. Follow up telephone conversations were performed post e-mail notifications. Firm worked with FDA to develop and coordinate a unified message that would be noticed on the websites of FDA, UNOS, and CDC. Firm also independently contacted the Association of Organ Procurement Organizations and UNOS to assist with messaging for their constituents. In the recall notification emails, customers were instructed to return affected product to Organ Recovery Systems. All affected product will be destroyed after completion of the firm's internal investigation. Upon learning of the additional lots of potentially contaminated product (PBR-0074-337 and PBR-0060-386), on 1/13/2017 ORS notified their customers via email and phone and updated the posting on their website. The instructions were only to quarantine the product, however. On January 23, 2017, firm began instructing their customers (via email) to return the additional affected lots to ORS. An update to their website was posted January 24, 2017. instructing affected customers to return the lots of product. For further questions regarding this recall, please call (847) 824-2421.

    Distribution

    Nationwide

    Quantity

    4,806 bags (3000 1 Liter bags, 1806 2-Liters bags)