BEUDAMED
    FDA Recall Terminated

    Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., Elkhorn, WI 53121. Manufactured for: BTL Solutions LLC, a subsidiary of Bridge to Life, Ltd., 1225 Laurel Street, Columbia, SC 29201.

    Recall: Z-0427-2011 · Initiated September 24, 2010

    Recall

    Recall Number
    Z-0427-2011
    Event Number
    56913
    Firm
    Preservation Solutions Inc
    FEI Number
    1000221028
    Product Code
    KDN
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    September 24, 2010
    Posted
    November 22, 2010
    Terminated
    April 2, 2012
    Address
    980 Proctor Dr. P.O. Box 937, Elkhorn, WI, 53121-0937

    Description

    Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., Elkhorn, WI 53121. Manufactured for: BTL Solutions LLC, a subsidiary of Bridge to Life, Ltd., 1225 Laurel Street, Columbia, SC 29201.

    Reason

    Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.

    Action

    Bridge to Life, Ltd, issued a Notification of Product Recall letter dated October 18, 2010 to all direct accounts identifying the affected product and labeling issue. Customers were informed that all product from the affected lot has been replaced by the firm. Customers with questions about this recall can contact Bridge to Life at 803 673-4548..

    Distribution

    Nationwide Distribution - in US to the states of CA, MO, and PA.

    Quantity

    55 units