Dialyzer, Capillary, Hollow Fiber
Gastroenterology, Urology · 21 CFR 876.5820
Recent MDR events
8,424 adverse event reports on file
- POLYFLUXJul 22, 2026InjuryVantive Us Healthcare Llc9611369-2026-00100
- POLYFLUXJul 22, 2026MalfunctionVantive Us Healthcare Llc9611369-2026-00101
- POLYFLUXJul 21, 2026MalfunctionVantive Us Healthcare Llc9611369-2026-00096
- POLYFLUXJul 21, 2026MalfunctionVantive Us Healthcare Llc9611369-2026-00097
- POLYFLUXJul 21, 2026MalfunctionVantive Us Healthcare Llc9611369-2026-00099
- POLYFLUXJul 20, 2026MalfunctionVantive Us Healthcare Llc9611369-2026-00094
- POLYFLUXJul 13, 2026MalfunctionVantive Us Healthcare Llc9611369-2026-00090
- POLYFLUXJul 13, 2026InjuryVantive Us Healthcare Llc9611369-2026-00091
- POLYFLUXJul 9, 2026MalfunctionVantive Us Healthcare Llc9611369-2026-00089
- POLYFLUXJul 2, 2026MalfunctionVantive Us Healthcare Llc9611369-2026-00087
Event type breakdown
Recalls
7 recall events for this product code
- Fresenius Medical Care Holdings, Inc.Open, ClassifiedOct 3, 2025
Optiflux High Flux E-beam Dialyzer
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
Z-0041-2026 · View FDA record ↗ - Fresenius Medical Care Renal Therapies Group, LLCTerminatedApr 5, 2016
Fresenius Hemoflow F3 Dialyzer
Dialyzer header leak due to possible improper torque
Z-1324-2016 · View FDA record ↗ - Asahi Medical Co., LtdTerminatedNov 14, 2006
Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a
There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.
Z-0175-2007 · View FDA record ↗ - Toray Marketing & Sales (America), IncTerminatedJan 14, 2004
Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H
Potential loose header (end cap) on hollow fiber dialyzers.
Z-0349-04 · View FDA record ↗ - Toray Marketing & Sales (America), IncTerminatedJan 14, 2004
Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a
Potential loose header (end cap) on hollow fiber dialyzers.
Z-0350-04 · View FDA record ↗ - Toray Marketing & Sales (America), IncTerminatedJan 14, 2004
Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU
Potential loose header (end cap) on hollow fiber dialyzers.
Z-0351-04 · View FDA record ↗ - Toray Marketing & Sales (America), IncTerminatedJan 14, 2004
Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8
Potential loose header (end cap) on hollow fiber dialyzers.
Z-0352-04 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
Fresenius Usa Manufacturing, Inc.
Ogden, UT, US
Gambro Dialysatoren Gmbh
HECHINGEN Baden-Wurttemberg, DE
Vantive Us Healthcare Llc
Deerfield, IL, US
Reprocessing Products Corporation (rpc)
TUCSON, AZ, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Fresenius Medical Care Renal Therapies Group, Llc
Waltham, MA, US
Molded Products Inc.
HARLAN, IA, US
Baxter S.a. De C.v.
CIVAC, JIUTEPEC, MORELOS, MX
510(k) clearances
131 clearances for this product code
- Fresenius Medical Care Renal Therapies Group, LLCAug 23, 2019
K190459 · Hemoflow F3 and F4 Dialyzers
- Nipro Medical CorporationDec 4, 2013
K122952 · NIPRO PUREFLUX-L HEMODIALYZER
- Gambro Renal ProductsMay 27, 2005
K043342 · POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
- Molded Products, Inc.Nov 28, 2001
K010366 · DISPOSABLE STORAGE CAP
- Interpore Cross Intl.Jun 13, 2001
K011148 · ULTRACONCENTRATOR SYSTEM
- Fresenius Medical Care North AmericaDec 4, 2000
K002761 · FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
- IdemsaApr 17, 2000
K991908 · IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
- Althin Medical ABSep 24, 1999
K992594 · A-15 HEMODIALYZER