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, PREGNANT, PREGNANT
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 (gravity and pump)
- Model numbers
- 490566, 04046955275625, 04046955275618
- 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
This IV administration set delivers fluids and medications in hospital and clinical settings and is designed for use with infusion pumps and gravity administration.
Why This Is Dangerous
Backflow into the primary IV line and occlusion of the line can cause incorrect dosing, delayed therapy, or contamination of medications.
Industry Context
This recall is not identified as part of a broader industry safety pattern in the provided information.
Real-World Impact
Hospitals must remove affected sets from use and obtain safe replacements to prevent dosing errors and potential patient harm.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 490566 on the product label.
- Verify Primary UDI-DI 04046955275625 and Unit of Dose UDI-DI 04046955275618.
- Confirm the product is part of BBMI Infusomat Space Large Volume Pump, Outlook Pump, or Vista Basic Pump setups.
Where to find product info
Labeling on the IV set and accompanying packaging; FDA recall page for Z-0718-2026 details.
What timeline to expect
Recalls in hospital supply chains typically take 4-8 weeks for full remediation and replacement stock.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a MedWatch/FDA recall complaint if manufacturer is unresponsive
- Consult legal counsel if patient harm occurs
How to prevent similar issues
- Verify catalog numbers and UDIs before stocking IV sets
- Source sets only from approved distributors
- Maintain an inventory log to isolate recalled lots quickly
- Educate staff on recall procedures for medical devices
Documentation advice
Document recall notice, supplier communications, inventory affected, and actions taken to remove and replace devices
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Product Details
Catalog Number: 490566. Primary UDI-DI: 04046955275625. Unit of Dose UDI-DI: 04046955275618. Expiration: Earliest Exp of Component or 36 months. Sold worldwide with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Brand: B Braun Medical
- UPC/UDI details on label
- Global distribution including US, Canada, Germany, Guatemala, Singapore
- Status: ACTIVE as of 2025-12-03
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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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