B. Braun Medical Inc. recalls 47,148 containers of 0.9% Sodium Chloride Injection USP nationwide after detecting particulate matter. The Class I recall affects bottles with NDC 0264-7800-09. Stop using and contact providers for guidance.
Presence of Particulate Matter.
Consumers and healthcare providers should stop using this product immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for guidance. Notification method: Letter
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0.9% Sodium Chloride Injection USP is a sterile IV fluid used to replenish lost fluids and electrolytes. It is administered in hospitals and clinics.
Particulate matter in IV solution can embolize or cause blockages, leading to severe complications or death if infused.
This recall is not part of a broader industry pattern.
Hospitals and clinics must halt use of the affected lot and manage inventory to prevent patient exposure; potential impact on patient safety and supply chains.
FDA enforcement report D-0628-2025 and official recall notices from B. Braun Medical Inc.
Remedies typically processed within 4-6 weeks; follow vendor and hospital policy for returns or replacements.
Retain recall notice, lot number, NDC, and correspondence with manufacturer for records
Model numbers: Lot # V3K770. Expiration: 01/31/2026. Quantity: 47,148 containers. Sold nationwide in the USA. Form: 1000 mL IV bags. Route: Intravenous use. Manufacturer: B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA. NDC: 0264-7800-09.
No specific injuries or incidents are disclosed in the provided data.
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