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FX CorAL 600 Dialyzer

Fresenius Medical Care Holdings, Inc. · Model F00009220 · UDI-DI 00840861102679

KDI Prescription

510(k) clearances

43,552

Adverse events (2,583 deaths)

217

Recalls

Facilities

Recalls

Date	Firm	Reason
2026-06-30	Fresenius Medical Care Renal Therapies Group, LLC	Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis ma
2026-05-11	Fresenius Medical Care Holdings, Inc.	Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
2026-01-06	VANTIVE US HEALTHCARE LLC	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06	VANTIVE US HEALTHCARE LLC	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06	VANTIVE US HEALTHCARE LLC	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06	VANTIVE US HEALTHCARE LLC	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06	VANTIVE US HEALTHCARE LLC	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06	VANTIVE US HEALTHCARE LLC	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06	VANTIVE US HEALTHCARE LLC	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2025-10-27	Nipro Medical Corporation	Screw may loosen or fallout of Hemodialysis system

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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.