FDA Drug recall D-0218-2024
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltha…
- FDA Drug
- Class II
- ongoing
- Published 2024-01-10
On 2024-01-10 the FDA classified a Class II recall of DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltha… by Fresenius Medical Care Holdings, citing lack of Sterility Assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0218-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-28 |
| Published | 2024-01-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
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
Lack of Sterility Assurance
Identifiers
| ndc | 49230-206-30 |
|---|---|
| ndc | 49230-206-32 |
| ndc | 49230-206-50 |
| ndc | 49230-206-52 |
| ndc | 49230-206-62 |
| ndc | 49230-209-30 |
| ndc | 49230-209-32 |
| ndc | 49230-209-50 |
| ndc | 49230-209-52 |
| ndc | 49230-209-62 |
| ndc | 49230-212-30 |
| ndc | 49230-212-32 |
| ndc | 49230-212-50 |
| ndc | 49230-212-52 |
| ndc | 49230-212-62 |
| code_info | Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0218-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.