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Home › Fresenius Medical Care Renal Therapies Group, LLC › 5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw

5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw

Fresenius Medical Care Renal Therapies Group, LLC · Model 03-5150-2 · UDI-DI 00840861102389

KOCFJK Prescription
1
510(k) clearances
1,221
Adverse events (17 deaths)
17
Recalls
49
Facilities

Recalls

DateFirmReason
2026-08-10Fresenius Medical Care Renal Therapies Group, LLCHeightened 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
2026-08-10Fresenius Medical Care Renal Therapies Group, LLCHeightened 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
2026-08-10Fresenius Medical Care Renal Therapies Group, LLCHeightened 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
2026-08-10Fresenius Medical Care Renal Therapies Group, LLCHeightened 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
2018-09-06Stihler Electronic GmbhPRISMAFLO 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
2018-09-06Stihler Electronic GmbhPRISMAFLO 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
2018-09-06Stihler Electronic GmbhPRISMAFLO 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
2016-05-24Fresenius Medical Care Renal Therapies Group, LLCUse 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.
2015-04-27Fresenius Medical Care Holdings, Inc.Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber
2015-01-20Molded Products IncA 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.