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
- Blood Administration Set
- Model numbers
- Catalog Number: 490196, Primary UDI-DI: 04046964303722, Unit of Dose UDI-DI: 04046964303715
- 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
Blood administration sets are used to deliver blood products via gravity or pumped IV systems. They connect to IV bags or containers and are used in hospital settings for transfusions.
Why This Is Dangerous
A backflow risk means medication could flow backwards from a secondary container into the primary line, potentially altering dosage. An occlusion can prevent proper priming and flow.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The recall could disrupt transfusion workflows and delay treatment in hospitals if affected sets remain in use.
Practical Guidance
How to identify if yours is affected
- 1) Locate Catalog Number 490196 on the packaging
- 2) Confirm Primary UDI-DI 04046964303722
- 3) Confirm Unit of Dose UDI-DI 04046964303715
- 4) Verify usage with Infusomat Space, Outlook, or Vista Basic Pumps
Where to find product info
Recall notices and instructions are available on the FDA enforcement page linked in the notice
What timeline to expect
Processing times for replacement or remedy are not specified; hospitals should coordinate with BBraun Medical and suppliers
If the manufacturer is unresponsive
- Document all communications
- Escalate to hospital procurement or risk management
- File a complaint with FDA if manufacturer or distributor is unresponsive
How to prevent similar issues
- Verify catalog numbers and UDIs before selecting IV sets
- Maintain a supplier audit for high-risk medical devices
- Keep recall and safety notices accessible to procurement staff
Documentation advice
Keep copy of the recall notice, model numbers, UDIs, purchase records, and all communications with the manufacturer and suppliers
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Product Details
Catalog Number: 490196. Primary UDI-DI: 04046964303722. Unit of Dose UDI-DI: 04046964303715. Sold worldwide, including US, Canada, Germany, Guatemala, and Singapore. Product description: Y-TYPE BLOOD SET 124 IN. Distribution: Worldwide distribution.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964303715
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- Hazard: backflow and occlusion risk; backflow from secondary to primary IV containers
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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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