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LifePort® Kidney Transporter

ORGAN RECOVERY SYSTEMS, INC. · Model CAN1000 · UDI-DI 00815045020315

KDL Prescription
1
510(k) clearances
60
Adverse events (3 deaths)
4
Recalls
14
Facilities

Description

LifePort® Kidney Transporter Disposable Coupler

Recalls

DateFirmReason
2024-01-09Dr Franz Koehler Chemie GmbhPotential for particles to be present in solution.
2016-12-14Organ Recovery Systems, Inc.Organ preservation fluid recalled due to potential for bacterial contamination.
2016-10-12Baxter Healthcare Corp.Potential presence of particulate matter on the blood side of the dialyzer
2012-03-30Teva Pharmaceuticals USA, Inc.Lack of assurance of sterility

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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.