DIANEAL Low Calcium — Class II drug recall D-831-2013
Terminated recall by Baxter Healthcare Corp., reported 2013-08-07, distributed nationwide. Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the po
| Recall number | D-831-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2013-07-24 |
| Classified | 2013-08-01 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2014-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 39,486 containers |
| Reason classes | 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 | 11/14, C886820 |
Product
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07
Reason for recall
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
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-831-2013. 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.