FDA Recalls Sodium Chloride Injection Due to Incomplete Container Seals
B. Braun Medical's 0.9% Sodium Chloride Injection batches recalled due to risk of incomplete seals that could allow leakage, potentially compromising sterility. The recall affects 1,343,982 bags distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II sterility defect recall for intravenous injection with potential contamination risk if seals fail. No reported illnesses or injuries, fitting the 'risk-of-harm without reported injury' criterion for score 3.
Plain-English summary
B. Braun Medical Inc. is recalling 1,343,982 bags of 0.9% Sodium Chloride Injection, USP in Excel Plus IV containers. The affected lots have a manufacturing defect that may result in incomplete seals near the port assembly of the container.
An incomplete seal can allow microscopic channel leaks in the product. Because this is a sterile intravenous solution intended for injection directly into the bloodstream, any leakage risks contamination with non-sterile material. The FDA classified this as a Class II recall due to the lack of sterility assurance.
The recalled batches were distributed nationwide to hospitals, healthcare facilities, and other medical institutions. If you have received any of the affected lots, do not use the product. Contact B. Braun Medical Inc. or your supplier for replacement stock or return instructions.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B. Braun Medical Inc.
- Category
- Drug — Intravenous Injection
- Affected units
- 1,343,982
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by B. Braun Medical Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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