FDA Drug recall D-0497-2026
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388…
- FDA Drug
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388… by B Braun Medical, citing lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0497-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-02 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
Reason
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Identifiers
| ndc | 0264-7388-50 |
|---|---|
| ndc | 0264-7388-60 |
| code_info | Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240…Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028. |
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-0497-2026%22
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