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 Extension Set
- Model numbers
- 490238, 04046964716409, 04046964716393
- 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 extension sets connect piggyback IV containers to the primary IV line. They are used in hospital and clinical settings to administer fluids and medications.
Why This Is Dangerous
Backflow from secondary to primary IV lines and inability to prime can affect IV therapy safety and effectiveness.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may need to quarantine affected lots and adjust IV administration workflows. The recall could impact supply chains for IV fluids and medications.
Practical Guidance
How to identify if yours is affected
- Locate catalog number on packaging (490238).
- Verify Primary UDI-DI: 04046964716409.
- Verify Unit of Dose UDI-DI: 04046964716393.
Where to find product info
FDA enforcement report and the manufacturer's recall notices.
What timeline to expect
Remedy processing timelines typically 4-6 weeks for replacement or refund, but patient impact may vary by facility.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- Escalate to hospital risk management and regulatory authorities if the manufacturer is unresponsive.
How to prevent similar issues
- In future purchases, verify UDI numbers and product labeling.
- Favor suppliers that provide clear recall checks and anti-backflow features where applicable.
- Maintain an updated list of recalled devices for facility-wide awareness.
Documentation advice
Keep recall notices, packaging images, catalog numbers, and all correspondence. Capture photos of affected units and note UDI codes.
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Product Details
Catalog Number: 490238 Primary UDI-DI: 04046964716409 Unit of Dose UDI-DI: 04046964716393 Description: EXT SET W/ 6 B/C VALVES, 17 IN Sold worldwide: US distribution and international distribution to Canada, Germany, Guatemala, and Singapore Price: Unknown When sold: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964716393
- Extensions Set with 6 B/C valves, 17 inches
- 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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