Home / Brands / Fresenius Medical Care Holdings
Fresenius Medical Care Holdings Recalls
166 recalls on record · July 4, 2012 to July 15, 2026 · Drugs, Medical Devices
Recalls by year
12
13
14
15
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
May 6, 2015Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371
Hazard: The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
May 6, 2015Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System -
Hazard: The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
May 6, 2015Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX,
Hazard: The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
February 11, 2015Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for
Hazard: Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
February 4, 2015Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hem
Hazard: Unqualified power assemblies shipped to customers.
October 1, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be
Hazard: Product was held at temperature above the labeled recommended storage temperature
September 24, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube u
Hazard: Products were held at improper storage temperature
September 24, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use
Hazard: Products were held at improper storage temperature
September 24, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single
Hazard: Products were held at improper storage temperature
September 24, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube
Hazard: Products were held at improper storage temperature
September 24, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tu
Hazard: Products were held at improper storage temperature
September 24, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use
Hazard: Products were held at improper storage temperature
June 18, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-L
Hazard: Container cap may contain foreign material- 0.60% - 0.80% Manganese
May 28, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to
Hazard: Naturalyte Liquid Bicarbonate maybe contaminated
May 28, 2014DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North Ameri
Hazard: Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..
May 21, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (200
Hazard: 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
May 21, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use wi
Hazard: 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
March 5, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
Hazard: Dialysate Port Leak During Priming of the Dialyzers
March 5, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
Hazard: Dialysate Port Leak During Priming of the Dialyzers
March 5, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment.
Hazard: Dialysate Port Leak During Priming of the Dialyzers
March 5, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
Hazard: Dialysate Port Leak During Priming of the Dialyzers
March 5, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
Hazard: Dialysate Port Leak During Priming of the Dialyzers
March 5, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
Hazard: Dialysate Port Leak During Priming of the Dialyzers
March 5, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
Hazard: Dialysate Port Leak During Priming of the Dialyzers
March 5, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.
Hazard: Dialysate Port Leak During Priming of the Dialyzers
March 5, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Hazard: Dialysate Port Leak During Priming of the Dialyzers
February 12, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a sock
Hazard: Bicarbonate Jug Adapter distributed prior to 510(k) approval
January 15, 2014Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis
Hazard: 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
November 20, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circui
Hazard: Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
November 20, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal
Hazard: Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss