FDA Drug recall D-0652-2025
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem
- FDA Drug
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem by B Braun Medical, citing lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0652-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-26 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Reason
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Identifiers
| ndc | 0264-7385-50 |
|---|---|
| ndc | 0264-7385-60 |
| code_info | Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027 |
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-0652-2025%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.