0 — Class II drug recall D-0916-2023
Terminated recall by B. Braun Medical Inc., reported 2023-07-19, distributed nationwide. Lack of assurance of sterility: bags have the potential to leak.
| Recall number | D-0916-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical Inc., Daytona Beach, FL, United States |
| Recall initiated | 2023-07-05 |
| Classified | 2023-07-13 |
| Reported by FDA | 2023-07-19 |
| Terminated | 2024-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 79,880 bags |
| Reason classes | sterility, packaging |
| NDC | 00264-5802, 00264-5802-00, 00264-5802-10, 00264-5804, 00264-5804-00 |
| Lot numbers | 0061858305, 0061858306 |
| Expiration dates | 2025-03-31 |
Product
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
Reason for recall
Lack of assurance of sterility: bags have the potential to leak.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0916-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.