Fresenius Medical Care Holdings, Inc.

Waltham, MA, United States

16

Total Recalls

0

Class I Recalls

5

Ongoing Recalls

Recalls by Fresenius Medical Care Holdings, Inc.

FDA Drug Class II Ongoing

0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10

May 27, 2025 Fresenius Medical Care Holdings, Inc. 3,651,468 containers units
FDA Drug Class II Ongoing

DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogeni

June 18, 2024 Fresenius Medical Care Holdings, Inc. 183 cases units
FDA Drug Class II Ongoing

DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.

December 28, 2023 Fresenius Medical Care Holdings, Inc. 69,590 bags units
FDA Drug Class II Terminated

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10

May 23, 2023 Fresenius Medical Care Holdings, Inc. 53,424 bags units
FDA Drug Class II Ongoing

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 0

November 22, 2022 Fresenius Medical Care Holdings, Inc. 4,097 cases/12 bags per case units
FDA Drug Class II Ongoing

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 0

October 11, 2022 Fresenius Medical Care Holdings, Inc. 16,006 cases of twelve bags each units
FDA Drug Class III Terminated

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius

April 28, 2021 Fresenius Medical Care Holdings, Inc. 285 cases units
FDA Drug Class III Terminated

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92

April 28, 2021 Fresenius Medical Care Holdings, Inc. 5 cases units
FDA Drug Class III Terminated

DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230

April 28, 2021 Fresenius Medical Care Holdings, Inc. 39 cases units
FDA Drug Class III Terminated

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50

April 28, 2021 Fresenius Medical Care Holdings, Inc. 25 cases units
FDA Drug Class II Terminated

Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10

April 28, 2021 Fresenius Medical Care Holdings, Inc. 48 cases units
FDA Drug Class III Terminated

DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50

April 28, 2021 Fresenius Medical Care Holdings, Inc. 49 cases units
FDA Drug Class III Terminated

DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, ND

April 28, 2021 Fresenius Medical Care Holdings, Inc. 4 cases units
FDA Drug Class III Terminated

DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50

April 28, 2021 Fresenius Medical Care Holdings, Inc. 672 cases units
FDA Drug Class II Terminated

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451

March 5, 2020 Fresenius Medical Care Holdings, Inc. 32,592 bags units
FDA Drug Class II Terminated

phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02

April 14, 2014 Fresenius Medical Care Holdings, Inc. 14,496 bottles units