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: 375258, Primary UDI-DI: 04046955256976, Unit of Dose UDI-DI: 04046955256969
- 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
Rate Flow IV Sets are used to deliver intravenous solutions either by gravity or through infusion pumps in healthcare settings. They connect to IV containers and allow controlled flow into patients.
Why This Is Dangerous
Backflow from secondary to primary IV containers may occur, risking unintended dosing or contamination. Inability to prime increases risk of under-infusion or occlusion.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinics may need to replace affected sets promptly to prevent potential medication backflow and priming failures, affecting patient care operations and budgets.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 375258 on the device packaging or label.
- Verify Primary UDI-DI 04046955256976 and Unit of Dose UDI-DI 04046955256969.
- Confirm expiration based on the component expiry or 36 months from manufacture.
Where to find product info
UDI-DI and catalog numbers are typically printed on the tubing set packaging and on the device label.
What timeline to expect
Refunds or replacements are typically processed within 4-6 weeks after verification.
If the manufacturer is unresponsive
- Document all communications with the supplier.
- Escalate to hospital risk management or contact FDA if the supplier is unresponsive.
How to prevent similar issues
- Verify all IV sets against current recalls before use.
- Keep an updated inventory of IV sets and their lot/UDI numbers.
- Require backflow-prevention features where possible.
Documentation advice
Keep the recall notice, supplier correspondence, and replacement records. Photograph catalog numbers and UDIs for proof.
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Product Details
Catalog Number: 375258; Primary UDI-DI: 04046955256976; Unit of Dose UDI-DI: 04046955256969; Expiration Date: Earliest Exp of Component or 36 months; Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore; Quantity: 150,664 units; Sold distribution: Worldwide to hospitals and healthcare facilities.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046955256969
- Distribution: Worldwide; 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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