Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- B. Braun Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL
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 - Medical Devices; 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
- Product type
- Blood Administration Set
- Model numbers
- Catalog Number: 480233, Primary UDI-DI: 04046955083572, Unit of Dose UDI-DI: 04046955083565
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 29, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
Blood administration sets are used to deliver blood products and IV fluids in hospitals. They connect to pumps or gravity feeds for controlled infusion.
Why This Is Dangerous
Backflow from secondary to primary IV containers and failure to prime can lead to misdelivery of medications or volume errors.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt use and replace inventory, which can affect patient care workflow and supply management.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 480233 on the product label.
- Verify Primary UDI-DI 04046955083572.
- Verify Unit of Dose UDI-DI 04046955083565.
- Confirm distribution regions include the US, Canada, Germany, Guatemala, Singapore.
Where to find product info
Recall notification letter and FDA enforcement page linked in the recall notice.
What timeline to expect
4-6 weeks for processing and refunds/replacements where applicable.
If the manufacturer is unresponsive
- Document all contact attempts
- Escalate to hospital compliance or regulatory authorities if the vendor is unresponsive
- Use FDA recall resources for guidance and reporting if needed
How to prevent similar issues
- Maintain an up-to-date inventory of UDIs and catalog numbers
- Implement a recall-specific quarantine process for affected lots
- Train staff on identifying recall notices and follow-up procedures
Documentation advice
Keep the recall letter, inventory lists, and correspondence with the supplier; photograph packaging and catalog labels for records.
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Product Details
Catalog Number: 480233. Primary UDI-DI: 04046955083572. Unit of Dose UDI-DI: 04046955083565. Sold worldwide, including US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Sold since: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046955083565
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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