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Custodiol(R)
Dr. Franz Köhler Chemie GmbH · Model 4 x 2000 ml · UDI-DI 04033133420007
10
510(k) clearances
34
Adverse events (1 deaths)
6
Recalls
37
Facilities
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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