BEUDAMED
    FDA Recall 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 · Initiated February 26, 2018

    Recall

    Recall Number
    Z-1387-2018
    Event Number
    79378
    Firm
    Preservation Solutions, Inc.
    FEI Number
    1000221028
    Product Code
    KDN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 26, 2018
    Terminated
    September 9, 2022
    Address
    1099 Proctor Dr, Elkhorn, WI, 53121-2027

    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..

    Action

    An Urgent: Product Recall Notification letters, dated February 26, 2018, were sent to consignees. The instructions include, halting distribution of any 2 Liter bags in inventory; and, arranging for the return of affected units. Preservation Solutions, Inc. provided a notification letter for their consignees to provide to their customers. The letter instructed customers to return any 2 Liter bags to their supplier, and to complete and return the acknowledgement form.

    Distribution

    Worldwide Distribution -- USA and Europe.

    Quantity

    31,104 units