DELFLEX Peritoneal Dialysis Solution — Class II drug recall D-0604-2018
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2018-03-28, distributed nationwide. Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
| Recall number | D-0604-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States |
| Recall initiated | 2017-12-20 |
| Classified | 2018-03-20 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2019-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 3,734 cases |
| Reason classes | sterility, packaging |
| NDC | 49230-0206, 49230-0206-30, 49230-0206-32, 49230-0206-50, 49230-0206-52, 49230-0206-62, 49230-0209, 49230-0209-23, 49230-0209-30, 49230-0209-32, 49230-0209-50, 49230-0209-52, 49230-0209-62, 49230-0212, 49230-0212-30, 49230-0212-32, 49230-0212-50, 49230-0212-52, 49230-0212-62 |
| Expiration dates | 2019-08 |
Product
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
Reason for recall
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
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-0604-2018. 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.