FDA Device Intelligence
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Accessories, Blood Circuit, Hemodialysis

FDA product code KOC · Class 2 · Gastroenterology, Urology

137
Registered devices
1,220
Adverse events
17
Recalls
182
510(k) clearances

Devices with this code

Recent 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 bl
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 bl
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 bl
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 bl
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
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
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
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
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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.