Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- BBraun 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
- BBraun Medical
- Product type
- IV Administration Set
- Model numbers
- Catalog Number: 457506, Primary UDI-DI: 04046964716126, Unit of Dose UDI-DI: 04046964716119
- 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 enable IV drug delivery via gravity or pump systems. They connect the IV bag to the patient and may include piggyback configurations.
Why This Is Dangerous
Backflow from secondary to primary IV containers can lead to unintended dosing and contamination. Occlusion prevents proper priming of the line.
Industry Context
This recall is not described as part of a broader pattern in the provided data.
Real-World Impact
High risk to patients if backflow occurs or priming fails, potential for incorrect dosing or interrupted therapy.
Practical Guidance
How to identify if yours is affected
- Locate Catalog Number 457506 on the IV set package or device.
- Verify UDI-DI 04046964716126 (Primary) and 04046964716119 (Unit of Dose).
- Confirm BBMI Infusomat Space, Outlook, or Vista Basic pump usage.
Where to find product info
UDI and catalog numbers are on labeling; contact manufacturer for recall specifics.
What timeline to expect
The recall was announced by FDA enforcement with notice dated 2025-12-03; timelines for refunds or replacements are per manufacturer instructions.
If the manufacturer is unresponsive
- Document all contact attempts
- Escalate to manufacturer and FDA if needed
- Consider file a complaint with consumer protection if delays occur
How to prevent similar issues
- Verify device compatibility before use with BBMI pumps
- Use only approved IV sets from the same manufacturer
- Maintain updated recall watchlist for IV supplies
Documentation advice
Keep recall letter, packaging, device labeling, and all correspondence with manufacturer.
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Product Details
Catalog Number: 457506. Primary UDI-DI: 04046964716126. Unit of Dose UDI-DI: 04046964716119. Sold worldwide including US, Canada, Germany, Guatemala, Singapore. Quantity: 1,019 units. Brand: B Braun Medical Inc. Related pumps: BBMI Infusomat Space Large Volume Pump, Outlook Pump, Vista Basic Pump.
Reported Incidents
No injuries or incidents have been reported in the document provided.
Key Facts
- Unit of Dose UDI-DI 04046964716119
- 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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