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, PREGNANT, PREGNANT
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 352394, Primary UDI-DI 4046964293375, Unit of Dose UDI-DI 04046964293368
- 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 connect IV bags to patients and can be used with gravity drip systems or syringe/roller pumps. This recall covers a specific ULTRASITE set used with several BBMI pumps.
Why This Is Dangerous
Backflow from secondary to primary IV containers can alter dosing and may prevent proper priming of the line, posing patient safety risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may need to pause using affected IV sets and source replacements, which could affect infusion workflows and patient care timelines.
Practical Guidance
How to identify if yours is affected
- 1) Look for Catalog Number 352394 on packaging or device
- 2) Verify Primary UDI-DI 4046964293375
- 3) Confirm Unit of Dose UDI-DI 04046964293368
- 4) Check for recall notice and instructions from B. Braun Medical
Where to find product info
FDA recall page and manufacturer notice; packaging labeling
What timeline to expect
Typically 4-8 weeks for refunds or replacements
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- Escalate to hospital risk management or patient safety contacts
- File a consumer complaint with the FDA if necessary
How to prevent similar issues
- Verify UDI and catalog numbers before procurement
- Routinely review manufacturer recall notices for IV equipment
- Use infusion sets from trusted suppliers with clear recall histories
Documentation advice
Keep recall notice, product packaging, and correspondence; document serial numbers/UDI codes and dates of purchase; photograph labels.
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Product Details
Catalog Number: 352394 Primary UDI-DI: 4046964293375 Unit of Dose UDI-DI: 04046964293368 Quantity: 1,250 units Distribution: Worldwide distribution to US, Canada, Germany, Guatemala, and Singapore Recall Date: 2025-10-29 Manufacturer: B. Braun Medical Model/Line: ULTRASITE IV ADMIN SET 60DROP Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 4) Unit of Dose UDI-DI 04046964293368
- 6) Worldwide distribution to 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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