0 — Class II drug recall D-0346-2023
Completed recall by B. Braun Medical Inc., reported 2023-03-01, distributed nationwide. Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plu
| Recall number | D-0346-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical Inc., Daytona Beach, FL, United States |
| Recall initiated | 2023-02-10 |
| Classified | 2023-02-23 |
| Reported by FDA | 2023-03-01 |
| Distributed | Nationwide (US) |
| Quantity | 1,343,982 bags |
| Reason classes | sterility, packaging |
| NDC | 00264-5802, 00264-5802-00, 00264-5802-10, 00264-5804, 00264-5804-00 |
| Lot numbers | 0061786962, 0061787769, 0061797767, 0061797768, 0061797770, 0061797771, 0061797772, 0061797773, 0061797774, 0061797775, 0061797776, 0061812946, 0061812947, 0061812948, 0061812949, 0061812950, 0061816017, 0061816018, 0061816019, 0061816020, 0061816021, 0061816358, 0061816359, 0061816361, 0061816362, 0061816363, 0061816364, 0061818516, 0061818517, 0061818518, 0061821562, 0061821563, 0061821564, 0061823709, 0061823710, 0061823711, 0061823714, 0061823715, 0061823716, 0061824770 and 10 more |
| Expiration dates | 2023-11-30, 2024-04-30, 2024-05-31, 2024-06-30, 2024-07-31, 2024-08-31 |
Product
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Reason for recall
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.
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-0346-2023. 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.