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 Extension Set
- Model numbers
- 490358, 04046964642746, 04046964642739
- 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 extension set is used with gravity IV administration and pump systems to deliver medications and fluids. It connects medication containers to patients via IV lines.
Why This Is Dangerous
Backflow from secondary (piggyback) IV containers into primary IV containers can occur with these sets. The assembly may also fail to prime, leading to incorrect medication delivery.
Industry Context
This recall is not described as part of a broader industry pattern in the provided documentation.
Real-World Impact
Hospitals and clinics using these sets risk improper dosing. The recall affects 1,200 units distributed worldwide, creating potential patient safety and workflow disruptions.
Practical Guidance
How to identify if yours is affected
- 1. Look for Catalog Number 490358 on the device or packaging.
- 2. Verify Primary UDI-DI 04046964642746 and Unit of Dose UDI-DI 04046964642739.
- 3. Confirm the device was used with Infusomat Space Large Volume Pump, Outlook Pump, or Vista Basic Pump.
Where to find product info
UDI-DI numbers and Catalog Number appear on the product label and packaging. The recall page lists 490358 as the catalog reference and the two UDIs as identifiers.
What timeline to expect
The notice does not specify a remediation timeline.
If the manufacturer is unresponsive
- Document all inventory changes and follow up with B Braun Medical through official channels.
- Escalate to hospital procurement or risk management if response is slow.
How to prevent similar issues
- In the future, verify device compatibility with IV pumps before use.
- Keep an updated inventory of high-risk infusion components.
- Watch for recall notices from FDA and device manufacturers.
Documentation advice
Keep the recall notice, purchase orders, batch records, and correspondence with the manufacturer. Photograph affected items and document quantities in stock.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Catalog Number: 490358. Primary UDI-DI: 04046964642746. Unit of Dose UDI-DI: 04046964642739. Quantity: 1,200 units. Sold worldwide to hospitals and clinics, including US and international distribution to Canada, Germany, Guatemala, and Singapore.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity recalled: 1,200 units
- Unit of Dose UDI-DI: 04046964642739
- Sold worldwide to hospitals and clinics
- Recall date: 2025-10-29; Status: ACTIVE; Hazard level: HIGH
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.