Baxter recalls Dianeal PD-2 Peritonial Dialysis Solution with 1.5% dextrose in 3000mL Ambu-Flex II bags due to potential leaks from the Luer component. This could lead to contamination risks during dialysis.
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Baxter is recalling Dianeal PD-2 Peritonial Dialysis Solution with 1.5% dextrose in 3000mL Ambu-Flex II bags because of a potential leak risk from the Luer component. This could cause contamination during dialysis treatments if the solution is not sterile.
The Luer component in the bag may leak, potentially allowing contaminants to enter the dialysis solution. This could lead to infections or contamination if the solution is not properly sterile during treatment.
Patients using peritoneal dialysis with this specific solution are affected. Healthcare providers who administer the solution are at higher risk due to the critical nature of the treatment.
Check for the product code L5B5169, NDC 0941-0411-04, and lot number Y405201 on the bag. This solution was sold with a manufacturing date of October 2024.
Look for the product code L5B5169, NDC 0941-0411-04, and lot number Y405201 on the bag.
The recall indicates a potential leak risk from the Luer component, which could lead to contamination. Use only the recalled product if you have the specific lot number and product code.
The recall does not specify a remedy, so check with your healthcare provider for guidance on safe use or disposal.
The product was manufactured with lot number Y405201, expiring October 31, 2024.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall D-0543-2023 — Baxter Baxter Hello, I own a Baxter that is covered by recall D-0543-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
