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Fresenius Medical Care Holdings Recalls

166 recalls on record · July 4, 2012 to July 15, 2026 · Drugs, Medical Devices

Recalls by year

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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:

November 20, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use a
Hazard: Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
November 13, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed t
Hazard: Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis
July 17, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished
Hazard: Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
July 17, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System wit
Hazard: Cassette may leak during set up or during peritoneal dialysis treatment
February 20, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
Hazard: There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.
January 23, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Numbe
Hazard: GranuFlo Dry Acid Concentrate may show discoloration
January 23, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number
Hazard: GranuFlo Dry Acid Concentrate may show discoloration
January 23, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Numbe
Hazard: GranuFlo Dry Acid Concentrate may show discoloration
January 23, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Num
Hazard: GranuFlo Dry Acid Concentrate may show discoloration
January 23, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number:
Hazard: GranuFlo Dry Acid Concentrate may show discoloration
January 23, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number:
Hazard: GranuFlo Dry Acid Concentrate may show discoloration
January 23, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number:
Hazard: GranuFlo Dry Acid Concentrate may show discoloration
January 23, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number:
Hazard: GranuFlo Dry Acid Concentrate may show discoloration
January 23, 2013Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B
Hazard: GranuFlo Dry Acid Concentrate may show discoloration
July 4, 2012Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B
Hazard: Risk of Alkalosis with acetate containing dialysis acid concentrates
July 4, 2012Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08
Hazard: Risk of Alkalosis with acetate containing dialysis acid concentrates