DELFLEX Peritoneal Dialysis Solution with 4 — Class III drug recall D-0609-2021
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2021-06-16, distributed nationwide. Temperature Abuse: Product exposed to temperature outside specified limits.
| Recall number | D-0609-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2021-04-28 |
| Classified | 2021-06-09 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2021-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 4 cases |
| Reason classes | temperature control |
| NDC | 49230-0206, 49230-0206-92, 49230-0206-94, 49230-0206-95, 49230-0209, 49230-0209-92, 49230-0209-94, 49230-0209-95, 49230-0212, 49230-0212-92, 49230-0212-94, 49230-0212-95 |
| Lot numbers | 20PU04030 |
| Expiration dates | 2022-06-20 |
Product
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92
Reason for recall
Temperature Abuse: Product exposed to temperature outside specified limits.
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-0609-2021. 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.