Quick Facts at a Glance
- Recall Date
- August 18, 2025
- Hazard Level
- HIGH
- Brands
- B. Braun Medical Inc., Sodium Chloride
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- B. Braun Medical Inc., Sodium Chloride
- Product type
- Intravenous Solution (Sodium Chloride Injection)
- Model numbers
- Lot #: V3K770
- UPC codes
- 0264-7800, 0264-7800-09
- Sizes
- 1000 mL
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 18, 2025
Reported by FDA DRUG
September 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Presence of Particulate Matter.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for guidance. Notification method: Letter
About This Product
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.
Why This Is Dangerous
Particulate matter in IV solution can embolize or cause blockages, leading to severe complications or death if infused.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
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.
Practical Guidance
How to identify if yours is affected
- Check NDC 0264-7800-09 on the container label.
- Match Lot number V3K770 and Expiration 01/31/2026.
- Verify 1000 mL bag size and Rx-only labeling.
Where to find product info
FDA enforcement report D-0628-2025 and official recall notices from B. Braun Medical Inc.
What timeline to expect
Remedies typically processed within 4-6 weeks; follow vendor and hospital policy for returns or replacements.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a report with supplier trading partners
- Contact FDA for guidance if manufacturer is unresponsive
How to prevent similar issues
- Implement lot-traceability checks at receiving
- Stock rotation to ensure oldest lots are used first
- Verify NDC before administration
- Maintain strict IV compounding protocols
Documentation advice
Retain recall notice, lot number, NDC, and correspondence with manufacturer for records
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Product Details
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.
Reported Incidents
No specific injuries or incidents are disclosed in the provided data.
Key Facts
- Class I recall
- Lot # V3K770
- Nationwide distribution in USA
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Safety Guide
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