FDA Medical Device Recalls (openFDA)
Preservation Solutions Inc: 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 number
- Z-0427-2011
- 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.
- Status
- Terminated
- Initiated
- 2010-09-24
- Posted
- 2010-11-22
- Terminated
- 2012-04-02
- Reason
- Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.
- 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 Customers were informed that all product from the affected lot has been replaced by the firm.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
- 55 units
- Distribution
- Nationwide Distribution - in US to the states of CA, MO, and PA.
- Lot, serial or model codes
- Batch # Bt017170, Lot# BC071710
- 510(k) numbers
- ["K073693"]
- PMA numbers
- not on file
- Product code
- KDN
- Firm FEI
- 1000221028
- Firm city
- Elkhorn
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28