FDA Drug recall D-0586-2025
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical…
- FDA Drug
- Class II
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical… by B Braun Medical, citing lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0586-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-04 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
Reason
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Identifiers
| ndc | 0264-7800-00 |
|---|---|
| ndc | 0264-7800-10 |
| ndc | 0264-7800-20 |
| ndc | 0264-7802-00 |
| ndc | 0264-7802-10 |
| code_info | Lot #: J5C919, Exp. 08/31/2027 |
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-0586-2025%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.