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Blood Tubing Lines for Hemodialysis

NIKKISO CO.,LTD. · Model AL-CDC-E(U) · UDI-DI 04987671100627

KOC Prescription

510(k) clearances

1,221

Adverse events (17 deaths)

Recalls

Facilities

Description

The BLOOD TUBING LINES FOR HEMODIALYSIS AL series(Sterilized by Ethylene Oxide) 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 DBB-06 PRO Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.

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.