Fresenius Medical Care Holdings recalls
Fresenius Medical Care Holdings appears in 167 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK,…
FDA Drug · Class II · 2022-10-26 · Fresenius Medical Care Holdings - AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems
FDA Device · Class II · 2022-09-28 · Fresenius Medical Care Holdings - AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems
FDA Device · Class II · 2022-09-28 · Fresenius Medical Care Holdings - AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Device · Class II · 2022-08-03 · Fresenius Medical Care Holdings - AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Device · Class II · 2022-08-03 · Fresenius Medical Care Holdings - NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic r…
FDA Device · Class II · 2022-07-20 · Fresenius Medical Care Holdings - NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic r…
FDA Device · Class II · 2022-07-20 · Fresenius Medical Care Holdings - AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US…
FDA Device · Class II · 2022-07-20 · Fresenius Medical Care Holdings - NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
FDA Device · Class II · 2022-07-13 · Fresenius Medical Care Holdings - Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
FDA Device · Class II · 2022-07-06 · Fresenius Medical Care Holdings - Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmona…
FDA Device · Class II · 2022-02-16 · Fresenius Medical Care Holdings - The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock c…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialys…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home se…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end sta…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation o…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysat…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of…
FDA Drug · Class III · 2021-06-16 · Fresenius Medical Care Holdings - DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 4…
FDA Drug · Class III · 2021-06-16 · Fresenius Medical Care Holdings - Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
FDA Drug · Class II · 2021-06-16 · Fresenius Medical Care Holdings - DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 250…
FDA Drug · Class III · 2021-06-16 · Fresenius Medical Care Holdings - DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b)…
FDA Drug · Class III · 2021-06-16 · Fresenius Medical Care Holdings - DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, N…
FDA Drug · Class III · 2021-06-16 · Fresenius Medical Care Holdings - DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius…
FDA Drug · Class III · 2021-06-16 · Fresenius Medical Care Holdings - DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b…
FDA Drug · Class III · 2021-06-16 · Fresenius Medical Care Holdings - AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and ino…
FDA Device · Class II · 2021-05-19 · Fresenius Medical Care Holdings - Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
FDA Device · Class II · 2021-02-10 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies So…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings