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.
FDA Recall Z-0427-2011 · Posted 2010-11-22
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Recalling FirmPreservation Solutions Inc
Recall StatusTerminated
Product CodeKDN
Date Initiated2010-09-24
Date Terminated2012-04-02
Product Quantity55 units
Reason for Recall
Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.
Firm 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 Customers were informed that all product from the affected lot has been replaced by the firm.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..
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution - in US to the states of CA, MO, and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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