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PERFADEX® Plus

Xvivo Perfusion AB · Model 19950 · UDI-DI 07350069520296

KDN Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 2 x 3000ml

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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Data 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.