Sodium Chloride Injection 1000ml (B. Braun) – Sterility Concern (2023)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
B. Braun Medical Inc.
Lot Codes / Batch Numbers
Lots: 0061786962 Exp. 11/30/2023, 0061797767 Exp. 04/30/2024, 0061797768 Exp. 05/31/2024, 0061787769 Exp. 05/31/2024, 0061797770 Exp. 05/31/2024, 0061797771 Exp. 05/31/2024, 0061797772 Exp. 05/31/2024, 0061797773 Exp. 05/31/2024, 0061797774 Exp. 05/31/2024, 0061797775 Exp. 05/31/2024, 0061797776 Exp. 05/31/2024, 0061812946 Exp. 05/31/2024, 0061812947 Exp. 05/31/2024, 0061812948 Exp. 05/31/2024, 0061812949 Exp. 05/31/2024, 0061812950 Exp. 05/31/2024, 0061816017 Exp. 06/30/2024, 0061816018 Exp. 06/30/2024, 0061816019 Exp. 06/30/2024, 0061816020 Exp. 06/30/2024, 0061816021 Exp. 06/30/2024, 0061816358 Exp. 06/30/2024, 0061816359 Exp. 06/30/2024, 0061816361 Exp. 07/31/2024, 0061816362 Exp. 07/31/2024, 0061816363 Exp. 07/31/2024, 0061816364 Exp. 07/31/2024, 0061818516 Exp. 07/31/2024, 0061818517 Exp. 07/31/2024, 0061818518 Exp. 07/31/2024, 0061821562 Exp. 08/31/2024, 0061821563 Exp. 08/31/2024, 0061821564 Exp. 08/31/2024, 0061823709 Exp. 08/31/2024, 0061823710 Exp. 08/31/2024, 0061823711 Exp. 08/31/2024, 0061823714 Exp. 08/31/2024, 0061823715 Exp. 08/31/2024, 0061823716 Exp. 08/31/2024, 0061824770 Exp. 08/31/2024, 0061824771 Exp. 08/31/2024, 0061824772 Exp. 08/31/2024, 0061824773 Exp. 08/31/2024, 0061824774 Exp. 08/31/2024, 0061824775 Exp. 08/31/2024, 0061824776 Exp. 08/31/2024, 0061824777 Exp. 08/31/2024, 0061826486 Exp. 08/31/2024, 0061826487 Exp. 08/31/2024, 0061826488 Exp. 08/31/2024
Products Sold
Lots: 0061786962 Exp. 11/30/2023; 0061797767 Exp. 04/30/2024; 0061797768 Exp. 05/31/2024; 0061787769 Exp. 05/31/2024; 0061797770 Exp. 05/31/2024; 0061797771 Exp. 05/31/2024; 0061797772 Exp. 05/31/2024; 0061797773 Exp. 05/31/2024; 0061797774 Exp. 05/31/2024; 0061797775 Exp. 05/31/2024; 0061797776 Exp. 05/31/2024; 0061812946 Exp. 05/31/2024; 0061812947 Exp. 05/31/2024; 0061812948 Exp. 05/31/2024; 0061812949 Exp. 05/31/2024; 0061812950 Exp. 05/31/2024; 0061816017 Exp. 06/30/2024; 0061816018 Exp. 06/30/2024; 0061816019 Exp. 06/30/2024; 0061816020 Exp. 06/30/2024; 0061816021 Exp. 06/30/2024; 0061816358 Exp. 06/30/2024; 0061816359 Exp. 06/30/2024; 0061816361 Exp. 07/31/2024; 0061816362 Exp. 07/31/2024; 0061816363 Exp. 07/31/2024; 0061816364 Exp. 07/31/2024; 0061818516 Exp. 07/31/2024; 0061818517 Exp. 07/31/2024; 0061818518 Exp. 07/31/2024; 0061821562 Exp. 08/31/2024; 0061821563 Exp. 08/31/2024; 0061821564 Exp. 08/31/2024; 0061823709 Exp. 08/31/2024; 0061823710 Exp. 08/31/2024; 0061823711 Exp. 08/31/2024; 0061823714 Exp. 08/31/2024; 0061823715 Exp. 08/31/2024; 0061823716 Exp. 08/31/2024; 0061824770 Exp. 08/31/2024; 0061824771 Exp. 08/31/2024; 0061824772 Exp. 08/31/2024; 0061824773 Exp. 08/31/2024; 0061824774 Exp. 08/31/2024; 0061824775 Exp. 08/31/2024; 0061824776 Exp. 08/31/2024; 0061824777 Exp. 08/31/2024; 0061826486 Exp. 08/31/2024; 0061826487 Exp. 08/31/2024; 0061826488 Exp. 08/31/2024
B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Be due to 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 possib. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026