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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:
February 16, 2022Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respir
Hazard: Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.
July 28, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equiva
Hazard: Exposed to freezing temperatures due to refrigerated truck malfunctions
July 28, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/discon
Hazard: Exposed to freezing temperatures due to refrigerated truck malfunctions
July 28, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped
Hazard: Exposed to freezing temperatures due to refrigerated truck malfunctions
July 28, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the prep
Hazard: Exposed to freezing temperatures due to refrigerated truck malfunctions
July 28, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component i
Hazard: Exposed to freezing temperatures due to refrigerated truck malfunctions
July 28, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in h
Hazard: Exposed to freezing temperatures due to refrigerated truck malfunctions
July 28, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the pr
Hazard: Exposed to freezing temperatures due to refrigerated truck malfunctions
July 28, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during
Hazard: Exposed to freezing temperatures due to refrigerated truck malfunctions
July 28, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients wit
Hazard: Exposed to freezing temperatures due to refrigerated truck malfunctions
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set,
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set,
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, W
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (ND
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Walth
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
May 19, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to rem
Hazard: AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2500 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation
February 10, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Numb
Hazard: Bottles Missing Product Label
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Re
Hazard: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Ren
Hazard: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Ren
Hazard: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius R
Hazard: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius R
Hazard: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius R
Hazard: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius R
Hazard: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius R
Hazard: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius R
Hazard: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
January 20, 2021Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius R
Hazard: The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.