Baxter Healthcare Corporation recalls Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx
Baxter recalls Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% dextrose (5000 mL) due to potential leaks from the Luer component. This could risk contamination during dialysis.
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Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
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What happened, in plain English
Baxter is recalling Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% dextrose (5000 mL) because the Luer component may leak, risking contamination during dialysis. Patients using this product should stop using it immediately. Read more at govinfonow.com/recall/33212-baxter-dianeal-pd-2-peritoneal-dialysis-solution-recall-potential-leaks.
Source Summary by GovInfoNow · govinfonow.com/recall/33212-baxter-dianeal-pd-2-peritoneal-dialysis-solution-recall-potential-leaks · Updated September 23, 2026 · FDA enforcement record: FDA #D-1141-2023
Cite this page
“Baxter Dianeal PD-2 Peritoneal Dialysis Solution Recall: Potential Leaks from Luer Component.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33212-baxter-dianeal-pd-2-peritoneal-dialysis-solution-recall-potential-leaks. Based on FDA recall #D-1141-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1141-2023%22&limit=1).
Why it’s dangerous
The Luer component in the container may leak, which could introduce contaminants into the dialysis solution. This poses a risk of infection or contamination during the dialysis process.
Who’s affected
Patients using the recalled Dianeal PD-2 Peritoneal Dialysis Solution for home dialysis. Those with the specific container model and lot number are most at risk.
How to tell if you have this one
Check for the yellow pull ring on the container. The product has a lot number Y406734 and expires October 31, 2024. It was sold with a prescription (Rx) only.
- Brand
Baxter- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA- NDC
0941-0411-05, 0941-0411-06, 0941-0411-07, 0941-0411-04, 0941-0411-11, 0941-0413-05, 0941-0413-06, 0941-0413-07, 0941-0413-01, 0941-0413-04, 0941-0415-05, 0941-0415-06, 0941-0415-04, 0941-0415-07, 0941-0415-01, 0941-0409-06, 0941-0409-05, 0941-0409-07, 0941-0409-01, 0941-0457-08, 0941-0457-02, 0941-0457-05, 0941-0457-01, 0941-0459-08, 0941-0459-02, 0941-0459-05, 0941-0459-01, 0941-0426-52, 0941-0426-53, 0941-0427-52, 0941-0427-53, 0941-0429-52, 0941-0429-53, 0941-0424-51, 0941-0424-52, 0941-0424-53, 0941-0430-51, 0941-0430-52, 0941-0430-53, 0941-0433-51, 0941-0433-52, 0941-0433-53, 0941-0484-01, 0941-0487-01, 0941-0490-01
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1140-2023 | 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.; a) Lots Y403948, Exp 30-Sep-2024; Lot Y406277, Exp 31-Oct-2024. b) Lot 408790, Exp 30-Nov-2024 and c) Lots Y403740, Y403740A, Exp 30-Sep-2024; Lots Y405638, Y405805, Y407304, Y407304A Exp 31-Oct-2024; Lots Y407717, Y407717A, Y408554, Exp 30-Nov-2024; Lot Y420075, Exp 30-Apr-2025 | a) 44,520; b) 60,762; c) 483,912 |
| D-1141-2023 | 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; Lot Y406734, Exp 31-Oct-2024 | 22,112 bags |
What to do — step by step
Stop Using It Now
Immediately stop using the recalled Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% dextrose (5000 mL) AMBU-FLEX ll Container with yellow pull ring.
Questions people ask
Is this product safe to use?
No, the product is recalled due to potential leaks from the Luer component, which could risk contamination during dialysis.
What is the product code?
The product code is L5B5193 with NDC 0941-0411-07.
How can I check if I have the recalled product?
Look for the yellow pull ring on the container, lot number Y406734, and expiration date of October 31, 2024.
Contact Baxter
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall D-1141-2023 — Baxter Baxter Hello, I own a Baxter that is covered by recall D-1141-2023 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1141-2023 (August 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1141-2023 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.