Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- B Braun Medical
- Category
- Health & Personal Care
- 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 - 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: 490451, Primary UDI-DI: 04046964848919, Unit of Dose UDI-DI: 04046964848902
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 deliver medications through IV lines. They connect to IV bags or reservoirs and to patient IV catheters. A recall indicates a risk of backflow and occlusion affecting drug delivery.
Why This Is Dangerous
Backflow from secondary to primary IV lines can result in improper dosing. Occlusion prevents proper priming and flow.
Industry Context
This recall does not indicate a broader industry pattern in this document.
Real-World Impact
Immediate halt of use is required to prevent potential medication delivery errors and patient harm.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 490451
- Look for expiration label indicating 36 months from manufacture
Where to find product info
UDI on packaging and device labeling; recall notice and FDA enforcement page
What timeline to expect
Remedies provided by the manufacturer; replacement or refund timelines vary by institution
If the manufacturer is unresponsive
- Document all communications
- Escalate to hospital risk management or supplier relations
- File complaint with FDA if manufacturer lacks remedy
How to prevent similar issues
- Verify device compatibility with pumps before purchase
- Use only labeled products with correct UDIs
- Follow hospital procurement standards to avoid recalled lots
Documentation advice
Keep recall notice, photos of catalog and UDIs, purchase receipts, and correspondence with supplier
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Product Details
Model numbers and details: Catalog Number 490451. Primary UDI-DI 04046964848919. Unit of Dose UDI-DI 04046964848902. Expiration date: Earliest expiration of component or 36 months. Quantity: 2,544 units. Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore.
Reported Incidents
No injuries or incidents information is provided in the memo. The status is ACTIVE with hazard level HIGH.
Key Facts
- Unit of Dose UDI-DI 04046964848902
- Expiration: earliest exp or 36 months
- Worldwide distribution (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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