FDA Class I Recall: B. Braun Sodium Chloride Injection for Particulate Matter
B. Braun Medical Inc. is recalling 63,444 containers of 0.9% Sodium Chloride Injection USP nationwide due to the presence of particulate matter. This intravenous medication may pose a serious health risk if administered to patients.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I drug recall as classified by the FDA. The hazard of particulate matter in intravenous medication poses a serious risk of harm if administered to patients, though no illnesses or injuries have been reported to date.
Plain-English summary
B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection USP, a prescription intravenous medication, due to the presence of particulate matter in the product. The recalled lots are J2L763 and J2L764, with an expiration date of March 31, 2025. The affected product comes in 1000mL containers (NDC 0264-7800-09).
The presence of particulate matter in an intravenous injection poses a serious risk of harm if administered to patients. This contamination could potentially cause complications if injected into the bloodstream.
The recalled product was distributed nationwide throughout the United States. Approximately 63,444 containers are affected by this recall.
Healthcare providers and patients who have this product should immediately stop using it and contact their healthcare provider or B. Braun Medical Inc. with questions. Pharmacies and hospitals should segregate and return the affected lots to the manufacturer. Do not use product from lots J2L763 and J2L764.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 63,444
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 (3)
- Lot #: J2L763
- J2L764
- Exp: 31 March 2025
Distribution
Distributed nationwide across the United States.
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