Quick Facts at a Glance
- Recall Date
- August 4, 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, PETS
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 Sodium Chloride Injection
- Model numbers
- Lot J5C919 Exp. 08/31/2027
- UPC codes
- 0264-7800, 0264-7802, 0264-7800-00, 0264-7800-10, 0264-7800-20, 0264-7802-00, 0264-7802-10
- Sizes
- 1000 mL
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 4, 2025
Reported by FDA DRUG
August 20, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
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 is a sterile IV solution used for various medical purposes in clinical settings.
Why This Is Dangerous
A lack of sterility can lead to infections or sepsis in patients receiving the infusion. Fluid leakage at a weld site can compromise sterility and product integrity.
Industry Context
This recall is not listed as part of a broader industry pattern in the provided data.
Real-World Impact
High relevance for hospitals and clinics. Potential disruption to IV therapy supply and patient safety if used.
Practical Guidance
How to identify if yours is affected
- Locate lot J5C919 on the container
- Check expiration date 08/31/2027
- Confirm Excel container and 1000 mL size
Where to find product info
FDA recall page and manufacturer recall notice; NDC 0264-7800-00 on label
What timeline to expect
Processing of replacement or refunds will be determined by the manufacturer and healthcare facilities; expect multi-week turnaround
If the manufacturer is unresponsive
- Escalate to hospital procurement lead
- File adverse event report with FDA if event occurs
- Consult distributor for replacement options
How to prevent similar issues
- Verify lot numbers before administration
- Maintain sterile handling procedures
- Stock-only from approved supply chain
- Review recall updates from FDA
Documentation advice
Keep copy of recall notice, lot J5C919, and expiration date; document communications with supplier and clinician
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Product Details
Lot number J5C919. Expiration 08/31/2027. 23,100 containers recalled. Excel Container, 1000 mL. NDC 0264-7800-00. Sold nationwide in the US. Class II recall.
Reported Incidents
No injury counts provided in the data.
Key Facts
- Lot # J5C919
- Nationwide distribution in the US
- Class II recall
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Safety Guide
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