Sodium Chloride, Sodium Lactate, Calci

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

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

9Reports
2Class I
1Ongoing
2024-07-17Most recent
2 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

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 II7
Class I2

By year reported

YearReports
20131
20142
20191
20234
20241
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.

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administr

D-0587-2024  ·  Class II  ·  reported 2024-07-17  ·  Ongoing

Why it was recalled
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Product
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01
Where it went
US Nationwide, Canada
How much
6,874 bags

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull

D-1141-2023  ·  Class II  ·  reported 2023-09-06  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Product
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07
Where it went
Nationwide in the USA
How much
22,112 bags

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX I

D-1140-2023  ·  Class II  ·  reported 2023-09-06  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Product
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Where it went
Nationwide in the USA
How much
a) 44,520; b) 60,762; c) 483,912

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only,

D-0543-2023  ·  Class II  ·  reported 2023-05-03  ·  Completed

Why it was recalled
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Product
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.
Where it went
Nationwide in the USA
How much
9,788 bags

Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Am

D-0542-2023  ·  Class II  ·  reported 2023-05-03  ·  Completed

Why it was recalled
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Product
Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Where it went
Nationwide in the USA
How much
a) 95,448 bags; b) 174,522 bags

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container ba

D-0351-2019  ·  Class II  ·  reported 2019-01-16  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Product
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
Where it went
Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
How much
29,370 bags
Class I

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II containe

D-1610-2014  ·  Class I  ·  reported 2014-10-08  ·  Terminated

Why it was recalled
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Product
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.
Where it went
Nationwide
How much
50,530 bags
Class I

Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter

D-1276-2014  ·  Class I  ·  reported 2014-05-07  ·  Terminated

Why it was recalled
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Product
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
Where it went
Nationwide.
How much
27,169 containers

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, B

D-831-2013  ·  Class II  ·  reported 2013-08-07  ·  Terminated

Why it was recalled
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Product
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07
Where it went
Nationwide and Puerto Rico
How much
39,486 containers
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.

← All drug recalls