Dialyzer, high permeability with or without sealed dialysate system

FDA product code KDI · Class 2 · 97 devices · 7,141 reports · 178 deaths reported · 34 devices named in recalls

• Optiflux® 0500318E

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  1 recall6 deaths2,849 reports
• 2008® Series Hemodialysis Machines 190713

  Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  3 recalls37 deaths893 reports
• 2008T BlueStar Hemodialysis Machine 191126

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  5 recalls10 deaths441 reports
• 2008® Series Hemodialysis Machines 190766

  Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  4 recalls15 deaths370 reports
• 2008T BlueStar Hemodialysis Machine 191130

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  4 recalls7 deaths272 reports
• 2008® Series Hemodialysis Machines 190610

  Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  1 recall15 deaths335 reports
• Optiflux® 0500320E

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  2 recalls242 reports
• REVACLEAR 300

  Gambro Renal Products, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  3 recalls125 reports
• PRISMAFLEX SET M100

  Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system
  2 recalls1 death150 reports
• Optiflux® 0500325E

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  1 recall1 death198 reports
• Tablo(R) Hemodialysis System PN-0006000

  Outset Medical, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  4 recalls8 deaths46 reports
• prisMaxPrisMax System 955626

  Baxter Healthcare Corporation · Dialyzer, high permeability with or without sealed dialysate system
  4 recalls37 reports
• 2008T BlueStar Hemodialysis Machine 191124

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  4 recalls32 reports
• 2008® Series Hemodialysis Machines 190895

  Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  3 recalls2 deaths60 reports
• REVACLEAR 400

  Gambro Renal Products, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  3 recalls1 death44 reports
• 2008® Series Hemodialysis Machines 190858

  Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  2 recalls5 deaths81 reports
• 2008T BlueStar Hemodialysis Machine 191128

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  3 recalls5 deaths22 reports
• PRISMAFLEX SET M150

  Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system
  2 recalls1 death66 reports
• Prismaflex 7.20

  Gambro AB · Dialyzer, high permeability with or without sealed dialysate system
  3 recalls1 death8 reports
• Prismaflex 7.XX

  Gambro AB · Dialyzer, high permeability with or without sealed dialysate system
  3 recalls2 deaths4 reports
• Prismaflex 5.XX

  Gambro AB · Dialyzer, high permeability with or without sealed dialysate system
  3 recalls0 reports
• PRISMAFLEX SET HF1000

  Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system
  2 recalls41 reports
• PRISMAFLEX SET HF1400

  Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system
  2 recalls2 deaths32 reports
• PRISMAFLEX 7.21

  Gambro AB · Dialyzer, high permeability with or without sealed dialysate system
  2 recalls4 reports
• NXSTAGE CARTRIDGE EXPRESS CAR-172-C

  Nxstage Medical, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  101 reports
• PRISMAFLEX SET 107640US

  Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system
  1 recall26 reports
• Nipro SURDIAL DX Hemodialysis System MC+SDX01

  Nipro Medical Corporation · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 recall5 deaths26 reports
• PRISMAFLEX SET 107636US

  Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system
  1 recall9 reports
• PRISMAFLEX SET M60

  Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system
  1 recall9 reports
• NXSTAGE CARTRIDGE EXPRESS CAR-170-C

  Nxstage Medical, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  57 reports
• 2008® Series Hemodialysis Machines 190630

  Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  1 recall6 reports
• AK 98 955607

  Vantive Health GmbH · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 recall1 death6 reports
• Optiflux® 0500318N

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  2 deaths55 reports
• 5008X Hemodialysis Machine M204441

  Fresenius Medical Care Renal Therapies Group, LLC · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 recall4 reports
• therMaxTherMax Blood Warmer 955630

  Baxter Healthcare Corporation · Dialyzer, high permeability with or without sealed dialysate system
  1 recall1 report
• REVACLEAR Revaclear 400

  Gambro Dialysatoren GmbH · Dialyzer, high permeability with or without sealed dialysate system
  1 recall1 report
• 2008® Series Hemodialysis Machines 190908

  Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  1 recall0 reports
• Renaflo II Hemofilter HF 1200

  Medivators Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  2 deaths49 reports
• Dialog+® 710200L

  B.Braun Avitum AG · Dialyzer, high permeability with or without sealed dialysate system
  24 deaths42 reports
• Optiflux® 0500308E

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  28 reports
• NXSTAGE CARTRIDGE EXPRESS CAR-500

  Nxstage Medical, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 death26 reports
• FX CorAL F00012970

  Fresenius Medical Care AG · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  25 reports
• Optiflux® 0500320N

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  24 reports
• Revaclear 400

  Gambro Dialysatoren GmbH · Dialyzer, high permeability with or without sealed dialysate system
  24 reports
• NXSTAGE CARTRIDGE EXPRESS CAR-505

  Nxstage Medical, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  22 reports
• FX CorAL 80 Dialyzer F00009217

  Fresenius Medical Care Holdings, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  19 reports
• Dialog+® 710200S

  B.Braun Avitum AG · Dialyzer, high permeability with or without sealed dialysate system
  11 deaths17 reports
• Optiflux® 0500306E

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  13 reports
• NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-17H

  Nipro Medical Corporation · Dialyzer, high permeability with or without sealed dialysate system
  2 deaths12 reports
• PHOENIX 6023006700

  Gambro Dasco SPA · Dialyzer, high permeability with or without sealed dialysate system
  12 reports
• NIPRO Cellentia™-H Hemodialyzer Cellentia™-17H

  Nipro Medical Corporation · Dialyzer, high permeability with or without sealed dialysate system
  11 reports
• Nipro Set Blood Tubing Set A430/V912

  Nipro Medical Corporation · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  5 deaths11 reports
• therMaxTherMax Blood Warmer 955516

  Baxter Healthcare Corporation · Dialyzer, high permeability with or without sealed dialysate system
  11 reports
• Revaclear 300

  Gambro Dialysatoren GmbH · Dialyzer, high permeability with or without sealed dialysate system
  10 reports
• NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-21H

  Nipro Medical Corporation · Dialyzer, high permeability with or without sealed dialysate system
  9 reports
• Optiflux® 0500316N

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  1 death9 reports
• NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-19H

  Nipro Medical Corporation · Dialyzer, high permeability with or without sealed dialysate system
  3 deaths7 reports
• CAPIOX® HEMOCONCENTRATOR CX*HC11L

  Terumo Corporation · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  7 reports
• NIPRO Cellentia™-H Hemodialyzer Cellentia™-21H

  Nipro Medical Corporation · Dialyzer, high permeability with or without sealed dialysate system
  6 reports
• NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-25H

  Nipro Medical Corporation · Dialyzer, high permeability with or without sealed dialysate system
  6 reports
• FX CorAL 100 Dialyzer F00009218

  Fresenius Medical Care Holdings, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  5 reports
• REXEED 25S

  Asahikasei Medical Mt K.K. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  5 reports
• CLEARUM HS IBP4371

  Bellco Srl · Dialyzer, high permeability with or without sealed dialysate system
  5 reports
• Optiflux® Ultra 0500418E

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  4 reports
• POLYFLUX REVACLEAR MAX 110634

  Gambro Renal Products, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  4 reports
• Blood Circuit Set UF 500

  Gambro Uf Solutions, Inc · Dialyzer, high permeability with or without sealed dialysate system
  4 reports
• NXSTAGE CARTRIDGE CAR-124-C

  Nxstage Medical, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  4 reports
• Exeltra Dialyzer 170

  Baxter International Inc. · Dialyzer, high permeability with or without sealed dialysate system
  3 reports
• NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-15H

  Nipro Medical Corporation · Dialyzer, high permeability with or without sealed dialysate system
  3 reports
• FX CorAL F00012969

  Fresenius Medical Care AG · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  3 reports
• Dialog+® 710200K

  B.Braun Avitum AG · Dialyzer, high permeability with or without sealed dialysate system
  3 reports
• REVACLEAR Revaclear 300

  Gambro Dialysatoren GmbH · Dialyzer, high permeability with or without sealed dialysate system
  3 reports
• CLEARUM HS IBP4373

  Bellco Srl · Dialyzer, high permeability with or without sealed dialysate system
  3 reports
• Blood Circuit Set UF 500-HCT

  Nuwellis Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  3 reports
• Aquadex SmartFlow Console 120100

  Nuwellis Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  3 reports
• NXSTAGE CARTRIDGE EXPRESS WITH SPEEDSWAP CAR-535

  Nxstage Medical, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  3 reports
• NIPRO Cellentia™-H Hemodialyzer Cellentia™-15H

  Nipro Medical Corporation · Dialyzer, high permeability with or without sealed dialysate system
  2 deaths2 reports
• NIPRO Cellentia™-H Hemodialyzer Cellentia™-19H

  Nipro Medical Corporation · Dialyzer, high permeability with or without sealed dialysate system
  2 reports
• Hemocor HPH HPH Junior

  Medivators Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  2 reports
• Hemocor HPH HPH 400

  Medivators Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  2 reports
• Optiflux® Ultra 0500416E

  Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  2 reports
• Diacap® 720DH19

  B.Braun Avitum AG · Dialyzer, high permeability with or without sealed dialysate system
  2 reports
• CAPIOX® HEMOCONCENTRATOR CX*HC11S

  Terumo Corporation · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  2 reports
• POLYFLUX REVACLEAR 110633

  Gambro Renal Products, Inc. · Dialyzer, high permeability with or without sealed dialysate system
  2 reports
• CLEARUM HS IBP4370

  Bellco Srl · Dialyzer, high permeability with or without sealed dialysate system
  2 reports
• Exeltra Dialyzer 150

  Baxter International Inc. · Dialyzer, high permeability with or without sealed dialysate system
  1 report
• PRISMAFLEX SET 107643US

  Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system
  1 report
• Renaflo II Hemofilter HF 400

  Medivators Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 report
• Hemocor HPH HPH 700

  Medivators Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 report
• FX CorAL 60 Dialyzer F00009216

  Fresenius Medical Care Holdings, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 report
• FX CorAL F00012971

  Fresenius Medical Care AG · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 report
• Dialog+® 710200U

  B.Braun Avitum AG · Dialyzer, high permeability with or without sealed dialysate system
  1 report
• REXEED 21S

  Asahikasei Medical Mt K.K. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 report
• CAPIOX® HEMOCONCENTRATOR CX*HC05S

  Terumo Corporation · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 report
• CAPIOX® HEMOCONCENTRATOR CX*HC05L

  Terumo Corporation · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 report
• Polyflux 6H

  Gambro Dialysatoren GmbH · Dialyzer, high permeability with or without sealed dialysate system
  1 report
• NXSTAGE CARTRIDGE CAR-125-B

  Nxstage Medical, Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 report