FDA Drug recall D-0653-2025
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, N…
- FDA Drug
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, N… 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-0653-2025 |
| 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
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
Reason
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Identifiers
| ndc | 0264-7388-50 |
|---|---|
| ndc | 0264-7388-60 |
| code_info | Lot#: : J4C521, J4C516, J4C524, 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-0653-2025%22
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