Dianeal PD-2 Dialysis Solution (Baxter) – sterility concern (2023)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Lot Y406734, Exp 31-Oct-2024
Products Sold
Lot Y406734, Exp 31-Oct-2024
Baxter Healthcare Corporation is recalling Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with ye due to Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026