DELFLEX Peritoneal Dialysis Solution in Biofine container 1 — Class II drug recall D-0218-2024
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2024-01-10, distributed nationwide. Lack of Sterility Assurance
| Recall number | D-0218-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2023-12-28 |
| Classified | 2024-01-04 |
| Reported by FDA | 2024-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 69,590 bags |
| Reason classes | sterility |
| NDC | 49230-0206, 49230-0206-30, 49230-0206-32, 49230-0206-50, 49230-0206-52, 49230-0206-62, 49230-0209, 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 |
| Lot numbers | 23JK02010 |
| Model numbers | 077-60621 |
| Expiration dates | 2025-01-31 |
Product
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Reason for recall
Lack of Sterility Assurance
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-0218-2024. 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.