Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Gastroenterology, Urology · 21 CFR 876.5820
Recent MDR events
8,011 adverse event reports on file
- COMBISET BLOODLINEJul 31, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-02057
- COMBISET BLOODLINEJul 31, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-02058
- COMBISET BLOODLINEJul 31, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-02060
- COMBISET BLOODLINEJul 31, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-02059
- COMBISET BLOODLINEJul 31, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-02062
- FMC BLOODLINEJul 31, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-02063
- FMC BLOODLINEJul 31, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-02065
- COMBISET BLOODLINEJul 31, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-02064
- COMBISET BLOODLINEJul 30, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-02041
- COMBISET BLOODLINEJul 30, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-02042
Event type breakdown
Product problems
Reported product problem codes, most common first
Trend for “Fluid/Blood Leak”
Recalls
35 recall events for this product code
- B Braun Medical IncOpen, ClassifiedApr 15, 2026
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Z-1798-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedApr 15, 2026
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Z-1799-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedApr 15, 2026
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Z-1800-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedApr 15, 2026
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Z-1801-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedApr 15, 2026
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Z-1802-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedApr 15, 2026
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Z-1803-2026 · View FDA record ↗ - B BRAUN MEDICAL INCOpen, ClassifiedOct 22, 2025
Brand Name: Hemodialysis Bloodlines
The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
Z-0070-2026 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedSep 19, 2024
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Z-3173-2024 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedSep 19, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Z-3174-2024 · View FDA record ↗ - B Braun Medical IncOpen, ClassifiedSep 19, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Z-3175-2024 · View FDA record ↗
Registered firms
135 firms currently registered for this product code
Outset Medical, Inc.
San Jose, CA, US
Haemotronic De Mexico S De Rl
REYNOSA Tamaulipas, MX
Isomedix Operations, Inc
ONTARIO, CA, US
Erika De Reynosa, S.a. De C.v.
CD, REYNOSA Tamaulipas, MX
Sterigenics Us Llc
Grand Prairie, TX, US
Sterigenics Us Llc
Fort Worth, TX, US
Baja Fur S.a. De C.v.
Tijuana BC. Baja California, MX
Pt. Nipro Indonesia Jaya
Karawang Jawa Barat, ID
Tianyi Medical (thailand) Co., Ltd.
PLUAKDAENG DISTRICT Rayong, TH
Vantive Us Healthcare Llc
Deerfield, IL, US
B. Braun Medical Inc.
Allentown, PA, US
Quanta Dialysis Technologies Ltd
Warwick Warwickshire, GB
Fresenius Medical Care Renal Therapies Group, Llc
Waltham, MA, US
Steril Verona S.r.l.
ERBE Verona, IT
Sunder Biomedical Tech. Co., Ltd.
Yunlin County, TW
Gambro Renal Products S.a. De C.v.
TIJUANA Baja California, MX
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi
Cankaya Ankara, TR
Isomedix Operations Inc.
SAN DIEGO, CA, US
B. Braun Medical Inc.
BETHLEHEM, PA, US
Erika De Reynosa, S.a. De C.v.
CD, REYNOSA Tamaulipas, MX
510(k) clearances
77 clearances for this product code
- Bain Medical Equipment (Guangzhou) Co., Ltd.May 15, 2026
K252423 · NovaLine Tubing Set for Hemodialysis (BL 124)
- Vital Healthcare Sdn. Bhd.Jan 16, 2026
K251341 · VITAL Tubing Sets for Hemodialysis
- Ningbo Tianyi Medical Appliance Co., Ltd.Oct 2, 2025
K251442 · TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
- Diality, Inc.Dec 20, 2024
K243607 · Moda-flx Hemodialysis System Cartridge (102121-001 )
- Fresenius Medical Care Renal Therapies Group, LLCMay 31, 2023
K213992 · CombiSet Hemodialysis Blood Tubing Set
- Outset Medical, Inc.Nov 26, 2021
K210782 · Tablo Cartridge
- Jiangxi Sanxin Medtec Co., Ltd.Sep 6, 2021
K202796 · SANSIN Tubing Sets for Hemodialysis
- Bain Medical Equipment (Guangzhou) Co., Ltd.Mar 10, 2021
K201866 · NovaLine Tubing Sets for Hemodialysis