93 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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2008T HD SYS. W/O CDX BLUESTAR
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023
2008T Hemodialysis System without CDX
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·June 3, 2024
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·March 12, 2020
Hemodialysis Delivery System, Software Version 2.x.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code KDI·September 29, 2021
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·August 8, 2024
Prismaflex Control Unit, software versions below 7.21
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code KDI·October 4, 2019
Prismaflex Control Unit, software versions below 7.21
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code KDI·October 4, 2019
Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 17, 2024
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·June 3, 2024
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
FDA Recall
Open, Classified
·Outset Medical, Inc.·Product code KDI·August 1, 2024
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Recall
Open, Classified
·VANTIVE US HEALTHCARE LLC·Product code KDI·January 6, 2026
PrisMax System, Product Code 955724
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code KDI·March 15, 2022
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·June 3, 2024
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 17, 2024
2008T HD SYS. CDX BLUESTAR
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
FDA Recall
Open, Classified
·VANTIVE US HEALTHCARE LLC·Product code KDI·July 28, 2025
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
FDA Recall
Open, Classified
·VANTIVE US HEALTHCARE LLC·Product code KDI·July 28, 2025
PrisMax System, Product Code 955626
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code KDI·March 15, 2022
PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code KDI·March 15, 2022