Fresenius Medical Care Holdings recalls
FDA enforcement reports naming Fresenius Medical Care Holdings, Inc. as the recalling firm.
- Recall reports
- 18
- Class I (serious)
- 0
- Most recent report
- May 13, 2026
- May 13, 2026DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for…Drug · Fresenius Medical Care Holdings, Inc.Lack of Assurance of Sterility: Potential leaks from perforations in bags.Class II
- May 13, 2026DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for…Drug · Fresenius Medical Care Holdings, Inc.Lack of Assurance of Sterility: Potential leaks from perforations in bags.Class II
- Jul 2, 20250.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medi…Drug · Fresenius Medical Care Holdings, Inc.Lack of Assurance of SterilityClass II
- Jul 24, 2024DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4Drug · Fresenius Medical Care Holdings, Inc.This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.Class II
- Jan 10, 2024DELFLEX Peritoneal Dialysis Solution in Biofine container 1Drug · Fresenius Medical Care Holdings, Inc.Lack of Sterility AssuranceClass II
- Jun 7, 2023Sodium Chloride 0Drug · Fresenius Medical Care Holdings, Inc.Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.Class II
- Dec 14, 20220.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 m…Drug · Fresenius Medical Care Holdings, Inc.Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.Class II
- Oct 26, 20220.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 m…Drug · Fresenius Medical Care Holdings, Inc.Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.Class II
- Jun 16, 2021DELFLEX Peritoneal Dialysis Solution with 1Drug · Fresenius Medical Care Holdings, Inc.Temperature Abuse: Product exposed to temperature outside specified limits.Class III
- Jun 16, 2021Sodium Chloride 0Drug · Fresenius Medical Care Holdings, Inc.Temperature Abuse: Product exposed to temperature outside specified limits.Class II
- DELFLEX Peritoneal Dialysis Solution with 1
- DELFLEX Peritoneal Dialysis Solution with 2
- DELFELX Peritoneal Dialysis Solution with 4
- DELFLEX Peritoneal Dialysis Solution with 2
- DELFLEX Peritoneal Dialysis Solution with 4
- DELFLEX Peritoneal Dialysis Solution with 1
- Sodium Chloride 0
- phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for F…
Page 1 of 2