503 results · 25ms · Sources: EU EUDAMED, US FDA

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B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code FJK·March 19, 2026

STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies.

FDA Recall
Terminated ·Fresenius Medical Care Holdings, Inc.·Product code JKA·June 23, 2014

BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.

FDA Recall
Terminated ·Fresenius Medical Care Holdings, Inc.·Product code JKA·June 23, 2014

BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements, aluminum and zinc determination.

FDA Recall
Terminated ·Fresenius Medical Care Holdings, Inc.·Product code JKA·June 23, 2014

BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.

FDA Recall
Terminated ·Fresenius Medical Care Holdings, Inc.·Product code JKA·June 23, 2014

BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

FDA Recall
Terminated ·Fresenius Medical Care Holdings, Inc.·Product code JKA·June 23, 2014

NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

FDA Recall
Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·May 1, 2014

Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K

FDA Recall
Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 25, 2014

Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K

FDA Recall
Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 25, 2014

Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.

FDA Recall
Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·December 17, 2013

5008X CAREsystem +CLiC +CDX;

FDA Recall
Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·October 25, 2025

Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis

FDA Recall
Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code FJI·February 26, 2016

Stay Safe Cap

FDA Recall
Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDJ·October 10, 2023

Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

FDA Recall
Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·June 23, 2014

US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1

FDA Recall
Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FIP·May 16, 2024

BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in chemistry.

FDA Recall
Terminated ·Fresenius Medical Care Holdings, Inc.·Product code JKA·June 23, 2014

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

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