Sodium Chloride Irrigation Solution Recalled for Particulate Matter
B. Braun Medical Inc. is recalling a sodium chloride irrigation solution due to the presence of particulate matter. The product was distributed to 12 distributors who may have further distributed it 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text does not report any illnesses or injuries, and particulate matter in an irrigation solution is a manufacturing/quality defect rather than a high-risk pathogen or known hazard of serious harm, placing it in the Moderate category.
Plain-English summary
B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Irrigation USP, an isotonic solution for irrigation supplied in 500 mL plastic irrigation containers. The product is identified by NDC 0264-2201-10, Lot # J4K936, with an expiration date of 7/31/2027. The recall affects 32,256 bottles.
The recall is due to the presence of particulate matter in the product. The product was distributed to 12 distributors who may have further distributed the product nationwide.
Consumers or healthcare providers who have this product should stop using it and contact B. Braun Medical Inc. for further instructions regarding return or replacement of the affected lot.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Irrigation Solution
- Hazard
- Affected units
- 32,256
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 # J4K936
- Exp 7/31/2027
Distribution
Distributed nationwide across the United States.
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