FDA Drug recall D-0605-2021
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), 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 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), 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-0605-2021 |
| 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 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) 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 |
| ndc | 49230-0209-23 |
| code_info | Lot #: a) 20PU03043, Exp. Date June 2022; b) 20SU03036, Exp. date July 2022; c) 20Su07012, Exp. date July 2022; 21AU070…Lot #: a) 20PU03043, Exp. Date June 2022; b) 20SU03036, Exp. date July 2022; c) 20Su07012, Exp. date July 2022; 21AU07021, 21AU02037, 21AU01007, 21AU01006, 21AU01019, 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-0605-2021%22
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