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Belzer UW Cold Storage Solution
Bridge To Life Ltd. · Model BUW-006 · UDI-DI 00199284590434
1
510(k) clearances
38
Adverse events (1 deaths)
6
Recalls
37
Facilities
Description
For flushing and cold storage of kidney, liver, and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. 500mL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-20 | Paragonix Technologies Inc. | Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters. |
| 2025-06-12 | Bridge to Life Ltd | The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine |
| 2022-03-21 | Waters Medical Systems LLC | There is a potential for the WCM cassette pump head leaking solution. |
| 2020-01-30 | Organ Recovery Systems, Inc. | Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion. |
| 2018-02-26 | Preservation Solutions, Inc. | 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.. |
| 2010-09-24 | Preservation Solutions Inc | Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.