Medications & Supplements/Prescription Drugs

Dianeal Peritoneal Dialysis Solutions Recalled for Potential Sterility Loss

Agency Publication Date: April 24, 2023

Summary

Baxter Healthcare Corporation is recalling 105,236 bags of Dianeal Low Calcium and Dianeal PD-2 Peritoneal Dialysis Solutions due to a potential lack of sterility. The recall was initiated because of possible leaks originating from the Luer component of the dialysis bags. Using non-sterile dialysis solutions can introduce bacteria into the patient's body, which may lead to serious infections like peritonitis. No incidents or injuries have been reported at this time.

Risk

Leaks in the Luer connection component can compromise the sterile barrier of the dialysis fluid. If a patient uses a bag with a leak, contaminated fluid could enter their abdominal cavity, causing a high risk of severe internal infection.

What You Should Do

This recall affects Dianeal Low Calcium and Dianeal PD-2 Peritoneal Dialysis Solutions with 1.5% Dextrose, sold in 3000 mL, 5000 mL, and 6000 mL bags under the product codes L5B4826, L5B9770, and L5B5169.
Identify if your product is affected by checking the lot number and expiration date on the bag. Affected lots include Y406130, Y406314, Y406314A, Y406963, Y407199, and Y405201, all with an expiration date of October 31, 2024.
Verify the NDC numbers on the packaging: 0941-0409-07 (5000 mL), 0941-0409-01 (6000 mL), or 0941-0411-04 (3000 mL).
If you have health concerns or believe you have used a recalled bag, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact Baxter Healthcare Corporation for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose (5000 mL)

Variants: 1.5% Dextrose, 5000 mL

Model:

L5B4826

Lot Numbers:

Y406130 (Exp 31-Oct-2024)

NDC:

0941-0409-07

Packaged in Ambu-Flex II Container bag.

Product: Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose (6000 mL)

Variants: 1.5% Dextrose, 6000 mL

Model:

L5B9770

Lot Numbers:

Y406314 (Exp 31-Oct-2024)

Y406314A (Exp 31-Oct-2024)

Y406963 (Exp 31-Oct-2024)

Y407199 (Exp 31-Oct-2024)

NDC:

0941-0409-01

Packaged in Ambu-Flex II Container bag.

Product: Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose (3000 mL)

Variants: 1.5% Dextrose, 3000 mL

Model:

L5B5169

Lot Numbers:

Y405201 (Exp 31-Oct-2024)

NDC:

0941-0411-04

Packaged in Ambu-Flex II Container bag.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91883

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Sold By: Hospitals; Dialysis Centers; Pharmacies

Manufactured In: United States

Units Affected: 2 products (a) 95,448 bags; b) 174,522 bags; 9,788 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 · 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.

Summary

What You Should Do

This recall affects Dianeal Low Calcium and Dianeal PD-2 Peritoneal Dialysis Solutions with 1.5% Dextrose, sold in 3000 mL, 5000 mL, and 6000 mL bags under the product codes L5B4826, L5B9770, and L5B5169.

Identify if your product is affected by checking the lot number and expiration date on the bag. Affected lots include Y406130, Y406314, Y406314A, Y406963, Y407199, and Y405201, all with an expiration date of October 31, 2024.

Verify the NDC numbers on the packaging: 0941-0409-07 (5000 mL), 0941-0409-01 (6000 mL), or 0941-0411-04 (3000 mL).

If you have health concerns or believe you have used a recalled bag, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact Baxter Healthcare Corporation for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose (5000 mL)

Variants: 1.5% Dextrose, 5000 mL

Model:

L5B4826

Lot Numbers:

Y406130 (Exp 31-Oct-2024)

NDC:

0941-0409-07

Packaged in Ambu-Flex II Container bag.

Product: Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose (6000 mL)

Variants: 1.5% Dextrose, 6000 mL

Model:

L5B9770

Lot Numbers:

Y406314 (Exp 31-Oct-2024)

Y406314A (Exp 31-Oct-2024)

Y406963 (Exp 31-Oct-2024)

Y407199 (Exp 31-Oct-2024)

NDC:

0941-0409-01

Packaged in Ambu-Flex II Container bag.

Product: Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose (3000 mL)

Variants: 1.5% Dextrose, 3000 mL

Model:

L5B5169

Lot Numbers:

Y405201 (Exp 31-Oct-2024)

NDC:

0941-0411-04

Packaged in Ambu-Flex II Container bag.