Dianeal PD-2 Peritonial Dialysis Solution with 1 — Class II drug recall D-1141-2023
Terminated recall by Baxter Healthcare Corporation, reported 2023-09-06, distributed nationwide. Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
| Recall number | D-1141-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-08-11 |
| Classified | 2023-08-29 |
| Reported by FDA | 2023-09-06 |
| Terminated | 2024-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 22,112 bags |
| Reason classes | sterility, packaging |
| NDC | 00941-0409, 00941-0409-01, 00941-0409-05, 00941-0409-06, 00941-0409-07, 00941-0411, 00941-0411-04, 00941-0411-05, 00941-0411-06, 00941-0411-07, 00941-0411-11, 00941-0413, 00941-0413-01, 00941-0413-04, 00941-0413-05, 00941-0413-06, 00941-0413-07, 00941-0415, 00941-0415-01, 00941-0415-04, 00941-0415-05, 00941-0415-06, 00941-0415-07, 00941-0424, 00941-0424-51 and 35 more |
| Lot numbers | Y406734 |
| Expiration dates | 2024-10-31 |
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
Reason for recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1141-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.