FDA Recall
Ongoing
2026 recordClass II
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Published
- May 13, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing
2026 recordClass II
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- July 2, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
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-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
by Fresenius Medical Care Holdings, Inc.
- Reason
- This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
- Published
- July 24, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
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.
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Sterility Assurance
- Published
- January 10, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
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
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
- Published
- June 7, 2023
- Distribution
- Product was distributed to 32 clinics in…
View recall →
FDA Recall
Ongoing
Historical recordClass II
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 02451, NDC 49230-300-10
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- Published
- December 14, 2022
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
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 02451, NDC 49230-300-10
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- Published
- October 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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 Medical Care NA, Waltham, MA 02451
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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, NDC 49230-212-92
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
This page lists recalls that name Fresenius Medical Care Holdings, Inc. as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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