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
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: 352447, Primary UDI-DI: 04046964181665, Unit of Use UDI-DI: 04046964181658
- 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
IV administration sets deliver fluids from IV bags to patients. This includes gravity sets and pump-compatible sets used with infusion systems.
Why This Is Dangerous
Backflow can deliver medication from piggyback lines into primaries, risking incorrect dosing. Inability to prime means no fluid flow may occur.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics using these sets may halt therapy for affected lots until replacement; patients could be exposed to dosing errors or contamination if backflow occurs.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 352447
- Verify Primary UDI-DI 04046964181665
- Verify Unit of Use UDI-DI 04046964181658
- Confirm product is labeled as V1782F UNIV IV SET W/0.2 MICRON FILTER
- Note that the device is used with BBMI Infusomat Space, Outlook Pump, and Vista Basic Pump
Where to find product info
Labeling on the product and packaging; Material labeling includes the two UDIs and catalog number
What timeline to expect
Remedies and replacements are typically arranged through the manufacturer with recall processes; expect several weeks for replacement
If the manufacturer is unresponsive
- Escalate to hospital risk management or compliance departments
- Contact FDA recall contact channels or the manufacturer for escalation
- Consider filing a consumer complaint with regulatory bodies if the company is unresponsive
How to prevent similar issues
- Verify device compatibility with your infusion pump model
- Check labeling for 0.2 micron filter specifications
- Use only recommended IV sets with your pump equipment
- Validate UDI and catalog numbers before use
Documentation advice
Keep a copy of recall notice, take photos of product labeling including UDIs, record dates of receipt and any communications with the manufacturer
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Catalog Number: 352447 Primary UDI-DI: 04046964181665 Unit of Use UDI-DI: 04046964181658 Model: V1782F UNIV IV SET W/0.2 MICRON FILTER Sold/Distributed: Worldwide (US distribution and international distribution to Canada, Germany, Guatemala, Singapore) Recall Date: 2025-10-29 Quantity: 100 units Price: Unknown Sold Through: Unknown Additional notes: Includes gravity IV sets and pump administration sets used with BBMI Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity recalled: 100 units
- Unit of Use UDI-DI: 04046964181658
- Product: V1782F UNIV IV SET W/0.2 MICRON FILTER
- Distribution: Worldwide (US and international to Canada, Germany, Guatemala, Singapore)
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.