Z-0427-2011

Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage...

Name: Z-0427-2011 Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage...
Creator: Preservation Solutions Inc
Published: 2010-09-24
License: https://open.fda.gov/license/

Preservation Solutions Inc / initiated 2010-09-24 / Terminated / root cause: labeling and UDI

FDA source

Preservation Solutions Inc began a recall of Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs... on 2010-09-24. The reason FDA records is "Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0427-2011
Status: Terminated
Initiated: 2010-09-24
Posted: 2010-11-22
Terminated: 2012-04-02
Recalling firm: Preservation Solutions Inc
Product: 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.
Product code: KDN System, Perfusion, Kidney
Reason for recall: Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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 Customers were informed that all product from the affected lot has been replaced by the firm.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..
Quantity in commerce: 55 units
Distribution: Nationwide Distribution - in US to the states of CA, MO, and PA.
Product codes and lots: Batch # Bt017170, Lot# BC071710

Product code KDN

K073693Class IICostorsolPreservation Solutions, Inc. / cleared 2008-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)