Dialyzer, High Permeability With Or Without Sealed Dialysate System
Gastroenterology, Urology · 21 CFR 876.5860
Recent MDR events
43,552 adverse event reports on file
- 2008T HEMODIALYSIS SYSTEM W/BIBAGJul 31, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-02055
- 2008T HEMODIALYSIS SYSTEM W/BIBAGJul 31, 2026MalfunctionErika De Reynosa, S.a. De C.v.0008030665-2026-02056
- NxStage System OneJul 31, 2026MalfunctionNxstage Medical, Inc.3003464075-2026-00065
- Prismaflex Sets (Oxiris)Jul 31, 2026MalfunctionVantive Us Healthcare Llc8010182-2026-00615
- Prismaflex Sets (M)Jul 31, 2026MalfunctionVantive Us Healthcare Llc8010182-2026-00616
- PRISMAFLEX SETS (ST)Jul 31, 2026MalfunctionVantive Us Healthcare Llc8010182-2026-00617
- Prismaflex Sets (M)Jul 31, 2026MalfunctionVantive Us Healthcare Llc8010182-2026-00618
- Prismax MachinesJul 31, 2026MalfunctionVantive Us Healthcare Llc9616240-2026-00028
- Prismaflex Sets (St)Jul 31, 2026MalfunctionVantive Us Healthcare Llc8010182-2026-00619
- Thermax Blood Warmer UnitJul 31, 2026MalfunctionVantive Us Healthcare Llc9616240-2026-00029
Event type breakdown
Recalls
216 recall events for this product code
- Fresenius Medical Care Holdings, Inc.Open, ClassifiedJul 8, 2026
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions.
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Z-2702-2026 · View FDA record ↗ - VANTIVE US HEALTHCARE LLCOpen, ClassifiedFeb 2, 2026
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Z-1224-2026 · View FDA record ↗ - VANTIVE US HEALTHCARE LLCOpen, ClassifiedFeb 2, 2026
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Z-1225-2026 · View FDA record ↗ - VANTIVE US HEALTHCARE LLCOpen, ClassifiedFeb 2, 2026
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Z-1226-2026 · View FDA record ↗ - VANTIVE US HEALTHCARE LLCOpen, ClassifiedFeb 2, 2026
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Z-1227-2026 · View FDA record ↗ - VANTIVE US HEALTHCARE LLCOpen, ClassifiedFeb 2, 2026
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Z-1228-2026 · View FDA record ↗ - VANTIVE US HEALTHCARE LLCOpen, ClassifiedFeb 2, 2026
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Z-1229-2026 · View FDA record ↗ - VANTIVE US HEALTHCARE LLCOpen, ClassifiedFeb 2, 2026
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Z-1230-2026 · View FDA record ↗ - Fresenius Medical Care Holdings, Inc.Open, ClassifiedDec 17, 2025
5008X CAREsystem +CLiC +CDX;
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Z-0936-2026 · View FDA record ↗ - Nipro Medical CorporationOpen, ClassifiedDec 11, 2025
Hemodialysis System, Surdial DX
Screw may loosen or fallout of Hemodialysis system
Z-0912-2026 · View FDA record ↗
Registered firms
273 firms currently registered for this product code
Sorin Group Italia S.r.l
MIRANDOLA Modena, IT
Vantive Healthcare Technologies Private Limited
Bangalore Karnataka, IN
Fresenius Medical Care Renal Therapies Group, Llc
Waltham, MA, US
Steriservices
Bernay Eure, FR
Erika De Reynosa, S.a. De C.v.
CD, Reynosa Tamaulipas, MX
Baja Fur S.a. De C.v.
Tijuana BC. Baja California, MX
Sterigenics Us Llc
Fort Worth, TX, US
Fresenius Usa Manufacturing, Inc.
Ogden, UT, US
Isomedix Operations, Inc
ONTARIO, CA, US
Baja Fur S.a. De C.v.
Tijuana Baja California, MX
Nipro Corporation Odate Factory
ODATE-SHI Akita, JP
Zapalign Llc
Fort Lauderdale, FL, US
Vantive Us Healthcare Llc
Deerfield, IL, US
B. Braun Avitum Ag
GLANDORF Lower Saxony, DE
Quanta Dialysis Technologies Ltd
Warwick Warwickshire, GB
Gambro Industries
MEYZIEU CEDEX Rhone, FR
Infomed Sa
Meinier Geneve, CH
Sterlab
SIGNES Var, FR
Gambro Dasco S.p.a., Monitors Division
MEDOLLA Modena, IT
Medimexico, S. De R.l. De C.v.
TIJUANA Baja California, MX
510(k) clearances
345 clearances for this product code
- Fresenius Medical Care Renal Therapies Group, LLCJul 24, 2026
K261267 · Careflux H60;Careflux H70;Careflux V500
- Fresenius Medical Care Renal Therapies Group, LLCMay 15, 2026
K252377 · NxStage System One with NxView
- Nipro Medical CorporationMar 19, 2026
K260533 · ELISIO-H
- Fresenius Medical Care Renal Therapies Group, LLCFeb 10, 2026
K252459 · multiFlux 130 (F00013123); multiFlux 160 (F00013124)
- Outset Medical, Inc.Jan 26, 2026
K253412 · Tablo Hemodialysis System (PN-0008000, PN-0006000U)
- Fresenius Medical Care Renal Therapies Group, LLCDec 18, 2025
K253518 · FX CorAL 40; FX CorAL 50
- Medica USA, Inc.Sep 19, 2025
K243920 · Purema H Hemoconcentrator - Pediatric
- Vantive US Healthcare, LLCAug 1, 2025
K250508 · AK 98 Dialysis Machine (955607)