Dianeal Low Calcium — Class I drug recall D-1610-2014
Terminated recall by Baxter Healthcare Corp., reported 2014-10-08, distributed nationwide. Presence of Particulate Matter: particulate matter was found during the manufacturing process.
| Recall number | D-1610-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2014-08-07 |
| Classified | 2014-09-26 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2017-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 50,530 bags |
| Reason classes | specification failure |
| 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 | 05/16, C940700, C940841 |
Product
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.
Reason for recall
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
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-1610-2014. 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.