Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- B Braun Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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 Extension Set
- Model numbers
- V5405
- Sold at
- Unknown
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
This extension set is used to connect IV piggybacks or secondary bags to primary IV lines in hospital settings.
Why This Is Dangerous
Backflow could move medication from secondary to primary lines and occlusion could prevent proper flushing and dosing.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals must verify catalog numbers and stop using affected lots to prevent dosing errors.
Practical Guidance
How to identify if yours is affected
- Verify catalog number V5405 on the device label.
- Review hospital inventory for the affected units.
Where to find product info
Manufacturer recall notice and FDA enforcement page.
What timeline to expect
Refunds or replacements timelines will be determined by the manufacturer; no specific window provided here.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact patient safety liaison
- File recall report with regulatory agencies if needed
How to prevent similar issues
- Implement inventory controls to separate recalled units
- Train staff on recall actions
- Verify device compatibility with infusion pumps before use
Documentation advice
Keep recall letter, inventory lists, and correspondence with the manufacturer
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Product Details
Model numbers and identifiers: Catalog Number V5405. Primary UDI-DI 04046964188978. Unit of Dose UDI-DI 04046964188961. Quantity: 300 units. Distribution: Worldwide with US, Canada, Germany, Guatemala, Singapore.
Reported Incidents
No specific injuries or incidents are mentioned in the provided data. The status is ACTIVE with a HIGH hazard level.
Key Facts
- Catalog Number V5405
- Unit of Dose UDI-DI 04046964188961
- Global 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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