203 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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
5008X CAREsystem +CLiC +CDX;
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·October 25, 2025
Stay Safe Cap
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDJ·October 10, 2023
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
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
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
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - 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
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - 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
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - 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
190904 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
190828: 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
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 REF ASK-04020-MMC UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.
FDA Recall
Open, Classified
·ARROW INTERNATIONAL, LLC·Product code OFB·March 11, 2026
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle 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
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KPO·April 10, 2014
Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 17, 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 BlueStar Hemodialysis Machine, Model 191126 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 BlueStar Hemodialysis Machine, Model 191130 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