Sodium Chloride Injection Bags Recalled for Potential Leakage and Sterility Risk
B. Braun Medical Inc. is recalling 79,880 bags of Sodium Chloride Injection due to potential leakage that could compromise sterility. No illnesses or injuries have been reported.
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 recall of an intravenous drug with potential for sterility compromise due to leakage. Although contamination of IV solutions could cause serious harm, no illnesses or injuries have been reported, limiting the score to High per the rubric's criterion for risk-of-harm products without reported injury.
Plain-English summary
B. Braun Medical Inc. is recalling 79,880 bags of 0.9% Sodium Chloride Injection USP in 1000 mL Excel Plus Containers. The product was distributed nationwide in the United States. The affected lots are 0061858305 and 0061858306, with an expiration date of March 31, 2025.
The recall was issued because bags have the potential to leak, which compromises the sterility assurance of the product. Sodium Chloride Injection is a sterile solution intended for intravenous use.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B. Braun Medical Inc.
- Category
- Drug — Intravenous Solution
- Hazard
- Affected units
- 79,880
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 (2)
- Lot#: 0061858305
- 0061858306 Exp 3/31/2025
Distribution
Distributed nationwide across the United States.
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