Fresenius Medical Care Holdings, Inc. Provisional
FDA Flags (8)
Class II RecallMay 2026
Fresenius Medical Care Holdings, Inc.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2
Classification: Class II
Class II RecallMay 2026
Fresenius Medical Care Holdings, Inc.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,
Classification: Class II
Class II RecallJul 2025
Fresenius Medical Care Holdings, Inc.
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham,
Classification: Class II
Class II RecallJul 2024
Fresenius Medical Care Holdings, Inc.
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Se
Classification: Class II
Class II RecallJan 2024
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Med
Classification: Class II
Class II RecallJun 2023
Fresenius Medical Care Holdings, Inc.
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Wa
Classification: Class II
Class II RecallDec 2022
Fresenius Medical Care Holdings, Inc.
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,
Classification: Class II
Class II RecallOct 2022
Fresenius Medical Care Holdings, Inc.
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,
Classification: Class II