FDA Drug recall D-0076-2023
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc
- FDA Drug
- Class II
- terminated
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc by B Braun Medical, citing lack of sterility assurance: Bags have the potential to leak.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0076-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-11-25 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | FL, NJ, PA |
Product
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
Reason
Lack of sterility assurance: Bags have the potential to leak.
Identifiers
| ndc | 0264-5802-00 |
|---|---|
| ndc | 0264-5802-10 |
| ndc | 0264-5804-00 |
| ndc | 0061832446 |
| code_info | Lot: 0061832446 Exp. 31 Oct 2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0076-2023%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.