FDA Drug recall D-0608-2021
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 250…
- 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 and attached stay safe Exchange set, packaged in a) 250… 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-0608-2021 |
| 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 and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,
Reason
Temperature Abuse: Product exposed to temperature outside specified limits.
Identifiers
| ndc | 49230-206-92 |
|---|---|
| ndc | 49230-206-94 |
| ndc | 49230-206-95 |
| ndc | 49230-209-92 |
| ndc | 49230-209-94 |
| ndc | 49230-209-95 |
| ndc | 49230-212-92 |
| ndc | 49230-212-94 |
| ndc | 49230-212-95 |
| code_info | Lot #: a) 20PU02010, Exp. date June 2022 and b) 20SU04033, Exp. date July 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-0608-2021%22
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