BEUDAMED
    FDA Enforcement Class II Terminated

    Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient.

    Recall: Z-1387-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1387-2018
    Event ID
    79378
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Preservation Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 25, 2018
    Initiation Date
    February 26, 2018
    Classification Date
    April 16, 2018
    Termination Date
    September 9, 2022
    Address
    1099 Proctor Dr, Elkhorn, WI, 53121-2027, United States

    Description

    Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient.

    Reason

    Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..

    Code Info

    UDI 00810805000163, and UDI 00810805000071.

    Distribution

    Worldwide Distribution -- USA and Europe.

    Quantity

    31,104 units