FDA Recalls Sodium Chloride Injection for Particulate Matter Contamination
B. Braun Medical Inc. is recalling 47,148 containers of 0.9% Sodium Chloride Injection USP (Lot V3K770) distributed nationwide due to the presence of particulate matter. This contamination poses a serious risk to patients receiving intravenous therapy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall classification mandates a minimum severity of 4 per the rubric. Particulate matter contamination in injectable saline poses a serious risk to patients receiving intravenous therapy, despite no reported illnesses at the time of recall.
Plain-English summary
B. Braun Medical Inc. is recalling 47,148 containers of 0.9% Sodium Chloride Injection USP, 1000 mL containers (NDC 0264-7800-09, Lot #V3K770, Expiration 1/31/2026). This prescription injectable solution is used for intravenous therapy.
The FDA classified this as a Class I recall due to the presence of particulate matter detected in the product. Particulate contamination in injectable solutions represents a serious safety risk to patients receiving intravenous therapy.
The affected product was distributed nationwide across the United States. Healthcare facilities and pharmacies that received this lot should stop distribution and use immediately and quarantine the affected product.
Patients and healthcare providers who have the affected product or are considering its use should contact B. Braun Medical Inc. for assistance or consult their healthcare provider for guidance.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B BRAUN MEDICAL INC
- Hazard
- particulate-matter
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 #: V3K770
- Exp 1/31/2026
Distribution
Distributed nationwide across the United States.
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