Accessories, Blood Circuit, Hemodialysis
Gastroenterology, Urology · 21 CFR 876.5820
Recent MDR events
1,220 adverse event reports on file
- COMBISET ACCESS FLOW REVERSE CON TWISTERJul 1, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-01564
- COMBISETJun 17, 2026MalfunctionFresenius Medical Care Renal Therapies Group, Llc.MW5189643
- COMBISETJun 17, 2026MalfunctionFresenius Medical Care Renal Therapies Group, Llc.MW5189644
- COMBISETJun 17, 2026MalfunctionFresenius Medical Care Renal Therapies Group, Llc.MW5189645
- COMBISETJun 17, 2026MalfunctionFresenius Medical Care Renal Therapies Group, Llc.MW5189646
- COMBISETJun 17, 2026MalfunctionFresenius Medical Care Renal Therapies Group, Llc.MW5189647
- CLIC BLOOD CHAMBERJun 14, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-01207
- CLIC BLOOD CHAMBERJun 14, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-01208
- CLIC BLOOD CHAMBERMay 19, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-00959
- COMBISET ACCESS FLOW REVERSE CON TWISTERMay 8, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-00884
Event type breakdown
Recalls
13 recall events for this product code
- Molded Products IncTerminatedMar 24, 2017
Non-Sterile Double DIN to DIN "Y" Connector,
A customer relayed a complaint of a leaking dialysis tubing connector.
Z-1679-2017 · View FDA record ↗ - Fresenius Medical Care Holdings, Inc.TerminatedJun 5, 2015
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters
Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber
Z-1716-2015 · View FDA record ↗ - Fresenius Medical Care Holdings, Inc.TerminatedFeb 3, 2015
Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturati
Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
Z-1047-2015 · View FDA record ↗ - Molded Products IncTerminatedMar 18, 2013
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36.
The recalled product leaks at the connection site.
Z-0969-2013 · View FDA record ↗ - Fresenius Medical Care North AmericaTerminatedJan 23, 2009
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister)
Port may crack and separate resulting in potential blood exposure/blood loss for the patient
Z-0859-2009 · View FDA record ↗ - Fresenius Medical Care North AmericaTerminatedJan 23, 2009
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister)
Port may crack and separate resulting in potential blood exposure/blood loss for the patient
Z-0860-2009 · View FDA record ↗ - Baxter Healthcare Renal DivTerminatedMar 29, 2006
Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3005, 5M3005R
Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A Blood Monitor Pump and BM25 System ultrafiltration hemodialysis system.
Z-0681-06 · View FDA record ↗ - Horizon Medical Products IncTerminatedJul 20, 2004
Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile, Manufactured by: Horizon Medical Products, Inc.,
The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.
Z-1029-04 · View FDA record ↗ - Horizon Medical Products IncTerminatedJul 20, 2004
Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, DCL-800TEC 12 Fr. x 20.3cm, Manufactured by: Horizon Medical Products, Inc
The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.
Z-1030-04 · View FDA record ↗ - Stihler Electronic GmbhTerminatedUnknown
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex
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
Z-0759-2019 · View FDA record ↗
Registered firms
82 firms currently registered for this product code
Fresenius Medical Care Renal Therapies Group, Llc
Waltham, MA, US
Haemotronic De Mexico S De Rl
REYNOSA Tamaulipas, MX
Erika De Reynosa, S.a. De C.v.
CD, REYNOSA Tamaulipas, MX
Molded Products Inc.
HARLAN, IA, US
Innovations For Access, Inc.
Hillsboro, OR, US
Novosci Corp.
Conroe, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Platinum Focus Group Ltd.
London London, City of, GB
Erika Of Texas
Pharr, TX, US
Medimexico, S. De R.l. De C.v.
TIJUANA Baja California, MX
M.e.nikkiso Vietnam Co., Ltd.
Quang Ngai, VN
Isomedix Operations Inc.
SAN DIEGO, CA, US
Erika De Reynosa, S.a. De C.v.
CD, REYNOSA Tamaulipas, MX
Nipro Medical Corporation
Doral, FL, US
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Nikkiso Co., Ltd.
SHIBUYA-KU Tokyo, JP
Steris Corporation De Republica Dominicana, S.r.l.
Santo Domingo, DO
Medxl
ARDMORE, OK, US
Isomedix Operations Inc.
GRAND PRAIRIE, TX, US
510(k) clearances
182 clearances for this product code
- NIKKISO CO., LTD.May 15, 2025
K242176 · BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
- NIKKISO CO., LTD.May 15, 2025
K242479 · BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
- NIKKISO CO., LTD.Jul 28, 2023
K231589 · Blood Tubing Lines for Hemodialysis AV06C-E
- NIKKISO CO., LTD.Jun 16, 2023
K230514 · Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
- Fresenius Medical Care Renal Therapies Group, LLCSep 18, 2020
K201207 · CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
- Fresenius Medical Care Renal Therapies Group, LLCDec 14, 2017
K172238 · CAREline Airless Hemodialysis Blood Tubing Sets
- Fresenius Medical Care Renal Therapies Group, LLCApr 15, 2016
K160749 · CRIT-LINE III Blood Chamber II
- Fresenius Medical Care North AmericaNov 5, 2015
K152953 · CRIT-LINE CLIP (CLIC) BLOOD CHAMBER