BEUDAMED
    FDA Enforcement Class II 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 · Reported February 8, 2017

    Enforcement

    Recall Number
    Z-1111-2017
    Event ID
    75978
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Organ Recovery Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2017
    Initiation Date
    December 14, 2016
    Classification Date
    January 27, 2017
    Termination Date
    August 14, 2019
    Address
    1 Pierce Pl Ste 475, N/A, Itasca, IL, 60143-1253, United States

    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.

    Code Info

    Batch / Lot Number: PBR-0060-392, Reference Number: SPS1_1 LITER, Manufacturer Date: 06/22/2016, Expiration Date: 06/22/2018 ; Batch / Lot Number: PBR-0074-330, Reference Number: SPS1_2 LITER, Manufacturer Date: 07/13/2016, Expiration Date: 07/13/2018 Batch / Lot Number: PBR-0074-337 Batch / Lot Number: PBR-0060-386

    Distribution

    Nationwide

    Quantity

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