Dextrose Monohydrate, Sodium Chloride,

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride recalls: 9 FDA reports

Recalls involving Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride. What was wrong with each batch, and how the FDA graded the risk.

9Reports
0Class I
2Ongoing
2024-07-24Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class III5
Class II4

By year reported

YearReports
20181
20216
20242
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe E

D-0608-2024  ·  Class II  ·  reported 2024-07-24  ·  Ongoing

Why it was recalled
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Product
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
Where it went
Nationwide
How much
183 cases

DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fre

D-0218-2024  ·  Class II  ·  reported 2024-01-10  ·  Ongoing

Why it was recalled
Lack of Sterility Assurance
Product
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.
Where it went
Nationwide within the United States
How much
69,590 bags

DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Ex

D-0609-2021  ·  Class III  ·  reported 2021-06-16  ·  Terminated

Why it was recalled
Temperature Abuse: Product exposed to temperature outside specified limits.
Product
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
Where it went
Nationwide within the United States
How much
4 cases

DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2

D-0605-2021  ·  Class III  ·  reported 2021-06-16  ·  Terminated

Why it was recalled
Temperature Abuse: Product exposed to temperature outside specified limits.
Product
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) Rx only, Fresenius Medical Care NA Waltham, MA 02451
Where it went
Nationwide within the United States
How much
672 cases

DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exc

D-0608-2021  ·  Class III  ·  reported 2021-06-16  ·  Terminated

Why it was recalled
Temperature Abuse: Product exposed to temperature outside specified limits.
Product
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,
Where it went
Nationwide within the United States
How much
39 cases

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL ba

D-0610-2021  ·  Class III  ·  reported 2021-06-16  ·  Terminated

Why it was recalled
Temperature Abuse: Product exposed to temperature outside specified limits.
Product
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
Where it went
Nationwide within the United States
How much
285 cases

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exc

D-0607-2021  ·  Class III  ·  reported 2021-06-16  ·  Terminated

Why it was recalled
Temperature Abuse: Product exposed to temperature outside specified limits.
Product
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
Where it went
Nationwide within the United States
How much
5 cases

Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags

D-0389-2021  ·  Class II  ·  reported 2021-05-26  ·  Terminated

Why it was recalled
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Product
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451
Where it went
USA Nationwide
How much
709 cases

DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-

D-0604-2018  ·  Class II  ·  reported 2018-03-28  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Product
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
Where it went
Product was distributed throughout the United States to patients and clinics.
How much
3,734 cases
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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