FDA Drug recall D-0347-2023
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc
- FDA Drug
- Class II
- completed
- Published 2023-03-01
On 2023-03-01 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc by B Braun Medical, citing lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal t….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0347-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-02-10 |
| Published | 2023-03-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
Reason
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Identifiers
| ndc | 0264-5802-00 |
|---|---|
| ndc | 0264-5802-10 |
| ndc | 0264-5804-00 |
| ndc | 0061794230 |
| ndc | 0061794232 |
| ndc | 0061797779 |
| ndc | 0061797780 |
| ndc | 0061797781 |
| ndc | 0061797783 |
| ndc | 0061797784 |
| ndc | 0061797785 |
| ndc | 0061797786 |
| ndc | 0061797787 |
| ndc | 0061797788 |
| ndc | 0061809680 |
| code_info | Lots: 0061794230 Exp. 01/31/2024; 0061794232 Exp. 01/31/2024; 0061797779 Exp. 02/29/2024; 0061797780 Exp. 02/29/2024; 0…Lots: 0061794230 Exp. 01/31/2024; 0061794232 Exp. 01/31/2024; 0061797779 Exp. 02/29/2024; 0061797780 Exp. 02/29/2024; 0061797781 Exp. 02/29/2024; 0061797783 Exp. 02/29/2024; 0061797784 Exp. 03/31/2024; 0061797785 Exp. 03/31/2024; 0061797786 Exp. 03/31/2024; 0061797787 Exp. 03/31/2024; 0061797788 Exp. 03/31/2024; 0061809680 Exp. 04/30/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0347-2023%22
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