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BLOOD TUBING LINES FOR HEMODIALYSIS

NIKKISO CO.,LTD. · Model AV06C-P · UDI-DI 04987671201102

KOC Prescription

510(k) clearances

1,221

Adverse events (17 deaths)

Recalls

Facilities

Description

The BLOOD TUBING LINES FOR HEMODIALYS IS includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the NIKKISO DBB-06 Hemodialysis Delivery System.

Recalls

Date	Firm	Reason
2026-08-10	Fresenius Medical Care Renal Therapies Group, LLC	Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovol
2026-08-10	Fresenius Medical Care Renal Therapies Group, LLC	Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovol
2026-08-10	Fresenius Medical Care Renal Therapies Group, LLC	Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovol
2026-08-10	Fresenius Medical Care Renal Therapies Group, LLC	Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovol
2018-09-06	Stihler Electronic Gmbh	PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
2018-09-06	Stihler Electronic Gmbh	PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
2018-09-06	Stihler Electronic Gmbh	PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
2016-05-24	Fresenius Medical Care Renal Therapies Group, LLC	Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.
2015-04-27	Fresenius Medical Care Holdings, Inc.	Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber
2015-01-20	Molded Products Inc	A customer relayed a complaint of a leaking dialysis tubing connector.

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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.