283 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code KDI·July 8, 2013
Baxter Arena Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
FDA Recall
Terminated
·Baxter Healthcare Renal Div·Product code KDI·February 20, 2004
2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc. dba Renal Solutions·Product code KDI·April 1, 2013
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
FDA Recall
Terminated
·NxStage Medical, Inc.·Product code KDI·October 29, 2015
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Recall
Terminated
·B Braun Medical Inc·Product code KDI·April 1, 2016
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·November 5, 2018
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KDI·May 31, 2019
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KDI·May 31, 2019
Prismaflex System, Prismaflex Control Unit
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KDI·February 6, 2020
Prismaflex System, Prismaflex Control Unit
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KDI·February 6, 2020
Fresenius 2008K@home Series : Hemodialysis System
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·December 21, 2016
Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KDI·April 24, 2018
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·April 3, 2019
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KDI·January 28, 2021
Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KDI·January 28, 2021
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KDI·May 4, 2022
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by a physician. The device is intended to be used with hollow fiber or parallel plate dialyzers.
FDA Recall
Terminated
·Baxter Healthcare Renal Div·Product code KDI·August 31, 2009
Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient''s blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument incluide a high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities anbd automated chemical disinfection. The Meridian will operate in either the bicarbonate or acetate mode for concentrates.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt·Product code KDI·November 15, 2002
Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis
FDA Recall
Terminated
·Baxter Healthcare Renal Div·Product code KDI·September 19, 2011
Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
FDA Recall
Terminated
·Asahi Kasei Medical Co., Ltd., Okatomi Plant 4960 5 Chome Nakagawara Cho Nobeoka-shi Japan·Product code KDI·September 21, 2012