Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Dianeal Peritoneal Dialysis Solutions Recalled for Sterility Concerns

Agency Publication Date: August 29, 2023
Share:
Sign in to monitor this recall

Summary

Baxter Healthcare Corporation has recalled several lots of DIANEAL Low Calcium and Dianeal PD-2 Peritoneal Dialysis Solutions due to the potential presence of leaks at the Luer connection component. These solutions, used for dialysis treatment, are packaged in various container sizes including 2,000 mL, 5,000 mL, and 6,000 mL bags. The recall affects a significant volume of products, with individual product types ranging from 22,112 to 483,912 bags. No injuries or incidents have been reported to date.

Risk

A leak in the dialysis solution bag can compromise the sterility of the fluid. If contaminated fluid is used during treatment, it poses a high risk of infection or peritonitis to the patient.

What You Should Do

  1. This recall affects DIANEAL Low Calcium (2.5 mEq/L) and Dianeal PD-2 Peritoneal Dialysis Solutions with 1.5% Dextrose, packaged in AMBU-FLEX II containers.
  2. Check your supply for affected product codes L5B4825, L5B4826, L5B9770, or L5B5193. See the Affected Products section below for the full list of affected lot numbers and expiration dates.
  3. Stop using the recalled product immediately. Contact Baxter Healthcare Corporation or your medical supply distributor to arrange for the return of any affected stock.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose
Variants: 2000 mL AMBU-FLEX II Container bag, 5000 mL AMBU-FLEX II Container bag, 6000 mL AMBU-FLEX II Container bag
Model:
L5B4825
L5B4826
L5B9770
Lot Numbers:
Y403948 (Exp 30-Sep-2024)
Y406277 (Exp 31-Oct-2024)
408790 (Exp 30-Nov-2024)
Y403740 (Exp 30-Sep-2024)
Y403740A (Exp 30-Sep-2024)
Y405638 (Exp 31-Oct-2024)
Y405805 (Exp 31-Oct-2024)
Y407304 (Exp 31-Oct-2024)
Y407304A (Exp 31-Oct-2024)
Y407717 (Exp 30-Nov-2024)
Y407717A (Exp 30-Nov-2024)
Y408554 (Exp 30-Nov-2024)
Y420075 (Exp 30-Apr-2025)
NDC:
0941-0409-06
0941-0409-07
0941-0409-01

Rx Only. Quantities: a) 44,520; b) 60,762; c) 483,912 bags.

Product: Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose
Variants: 5000 mL AMBU-FLEX II Container with yellow pull ring
Model:
L5B5193
Lot Numbers:
Y406734 (Exp 31-Oct-2024)
NDC:
0941-0411-07

Rx Only. Quantity: 22,112 bags.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92931
Status: Resolved
Manufacturer: Baxter Healthcare Corporation
Sold By: Hospitals; Dialysis Centers; Pharmacies
Manufactured In: United States
Units Affected: 2 products (a) 44,520; b) 60,762; c) 483,912; 22,112 bags)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.