Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- B. Braun Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- IV Administration Set
- Model numbers
- Catalog Number: 354208, Primary UDI-DI: 04046964293818, Unit of Dose UDI-DI: 04046964293801, Expiration Date: Earliest Exp of Comp or 24mths.
- Sold at
- Multiple Retailers
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
IV administration sets are used to deliver fluids and medication through IV lines. This recall concerns gravity and pump-assisted administration sets compatible with BBMI infusion pumps.
Why This Is Dangerous
Backflow from piggyback containers into primary containers can misdeliver medication. Inability to prime increases risk of incorrect flow or no flow, potentially harming patients.
Industry Context
This recall is not described as part of a broader industry pattern in the summary provided.
Real-World Impact
Affected patients could experience incorrect dosing or interrupted therapy. The recall covers 126,050 units across multiple countries, highlighting a wide distribution.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number on packaging: 354208.
- Inspect Primary UDI-DI: 04046964293818.
- Inspect Unit of Dose UDI-DI: 04046964293801.
- Review Expiration Date: Earliest Exp of Components or 24 months.
Where to find product info
Official recall notices and the FDA enforcement page list catalog numbers and UDIs. Check the manufacturer’s guidance for instructions on handling or returning products.
What timeline to expect
Recall processing timelines are not specified. Typically exchanges or replacements can take several weeks.
If the manufacturer is unresponsive
- File a complaint with the FDA if you cannot obtain guidance from the manufacturer.
- Contact your hospital’s risk management department for interim measures.
How to prevent similar issues
- Verify IV sets and pumps compatibility before use.
- Keep records of catalog numbers and UDIs when procuring IV sets.
- Follow all manufacturer safeguards and recall communications for future purchases.
Documentation advice
Preserve the recall letter, packaging, and any troubleshooting notes. Photograph labels and UDIs for reference.
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Product Details
Catalog Number: 354208. Primary UDI-DI: 04046964293818. Unit of Dose UDI-DI: 04046964293801. Expiration: Earliest Exp of Components or 24 months. Sold worldwide; US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Quantity: 126,050 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964293801
- Expiration: Earliest Exp of Components or 24 months
- 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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