Dianeal PD-2 Peritoneal Dialysis Solution with 1 — Class I drug recall D-1276-2014
Terminated recall by Baxter Healthcare Corp., reported 2014-05-07, distributed nationwide. Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overp
| Recall number | D-1276-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2014-02-11 |
| Classified | 2014-04-25 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2015-07-22 |
| Distributed | Nationwide (US) |
| Quantity | 27,169 containers |
| Reason classes | microbial contamination, sterility, specification failure, packaging |
| Pathogens | mold |
| 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 | 05/15, C903799 |
Product
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
Reason for recall
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
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-1276-2014. 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.