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SAMI Cassette

I-Dialco Inc · Model SA-400-00 · UDI-DI 07540161930226

KDI Prescription

510(k) clearances

43,984

Adverse events (2,610 deaths)

217

Recalls

Facilities

Description

The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.

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.