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: 490309, Primary UDI-DI: 04046964527517, Unit of Dose UDI-DI: 04046964527500
- 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 administration sets deliver fluids and medications through IV lines in hospital and clinical settings. This recall covers a gravity and pump-compatible set used with BBMI pumps such as Infusomat Space, Outlook, and Vista Basic. The affected units were distributed worldwide.
Why This Is Dangerous
Backflow from secondary (piggyback) IV containers into primary containers can cause dosing errors. Occlusion can prevent proper priming, stopping flow and delivery of medications.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics rely on IV sets for accurate medication delivery. The issue could lead to incorrect dosing or interrupted infusion, potentially compromising patient safety and treatment efficacy.
Practical Guidance
How to identify if yours is affected
- Check for catalog number 490309 on the device packaging.
- Verify Primary UDI-DI 04046964527517 and Unit of Dose UDI-DI 04046964527500.
- Confirm distribution includes US, Canada, Germany, Guatemala, Singapore.
Where to find product info
UDI-DI on label, package, and associated recall notices; recall URL in FDA enforcement page.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to hospital compliance or patient safety departments.
- Contact relevant regulatory authorities if the company is unresponsive.
How to prevent similar issues
- Verify device compatibility with the BBMI pump systems before procurement.
- Ensure backflow prevention features are present in IV sets before use.
- Request replacement products through the official recall process.
Documentation advice
Keep the recall notification letter, packaging photos, catalog numbers, and UDIs; record dates of contact and responses.
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Product Details
Catalog Number: 490309; Primary UDI-DI: 04046964527517; Unit of Dose UDI-DI: 04046964527500. Sold worldwide including US, Canada, Germany, Guatemala, Singapore. Price: Unknown. Sold since: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution including US, Canada, Germany, Guatemala, Singapore
- Unit of Dose UDI-DI 04046964527500
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Safety Guide
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