FDA Drug recall D-0610-2021
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b)…
- 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, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b)… 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-0610-2021 |
| 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, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
Reason
Temperature Abuse: Product exposed to temperature outside specified limits.
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 | Lot #: a) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, Exp. Date August 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-0610-2021%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.