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 Administration Set
- Model numbers
- Catalog Number: 354212, Primary UDI-DI: 04046964293832, Unit of Dose UDI-DI: 04046964293825
- 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
The Outlook IV Set is an infusion line used to deliver IV medications. It is compatible with various BBMI pump systems and is labeled for use in hospital and clinical settings.
Why This Is Dangerous
A backflow path can transfer medication from a secondary IV container into the primary line. Occlusion can prevent proper priming of the line, potentially compromising delivery and patient safety.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Healthcare facilities may need to remove the affected sets from inventory and switch to alternatives. The recall reduces the risk of unintended medication backflow and priming failure, but requires action from providers to re-source safe IV sets.
Practical Guidance
How to identify if yours is affected
- Check the catalog number on the packaging for 354212.
- Verify the Primary UDI-DI 04046964293832 on the device labeling.
- Verify the Unit of Dose UDI-DI 04046964293825 on the device documentation.
- If any identifiers match, stop using the device immediately.
- Follow the manufacturer's recall instructions for disposition.
Where to find product info
Identifiers are located on the device packaging and accompanying documentation. The FDA recall page provides official instructions.
What timeline to expect
Refunds or replacements are not specified in the recall; facilities should expect guidance to come from B Braun Medical with any replacement timing to
If the manufacturer is unresponsive
- File a consumer complaint with the FDA if the manufacturer is unresponsive
- Coordinate with the hospital procurement department to obtain approved alternatives
- Document all communications and retain the recall notice
How to prevent similar issues
- Always verify backflow-prevention features before selecting IV sets
- Confirm compatibility with infusion pumps in use
- Track recall notifications via hospital safety alerts
Documentation advice
Keep a copy of the recall notice, record correspondence with the manufacturer, and save replacement product details.
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Product Details
Model numbers: Catalog Number 354212. Where sold: Worldwide distribution including US, Canada, Germany, Guatemala, Singapore. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964293825
- Hazard: backflow and occlusion
- Worldwide distribution including 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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