FDA Drug recall D-0604-2021
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 4…
- FDA Drug
- Class III
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class III recall of DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 4… by Fresenius Medical Care Holdings, citing temperature Abuse: Product exposed to temperature outside specified limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0604-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-04-28 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
Reason
Temperature Abuse: Product exposed to temperature outside specified limits.
Identifiers
| code_info | Lot #: 20JU01001, Exp. Date February 2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0604-2021%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.