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
- 490412
- 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 IV administration set is used to deliver medications through gravity or pump-assisted IV systems. It connects to both primary and secondary IV lines and is designed for use in hospital or clinical settings.
Why This Is Dangerous
A backflow from a secondary (piggyback) container into the primary IV line can lead to incorrect dosing. The incapacity to prime the line increases the risk of incomplete or delayed medication delivery, potentially harming patients.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Healthcare providers must halt use of the affected sets to prevent potential medication errors. Hospitals may need to switch to alternative IV sets, impacting inventory and workflow.
Practical Guidance
How to identify if yours is affected
- 1. Locate catalog number on device labeling: 490412
- 2. Verify Primary UDI-DI: 04046964797989
- 3. Verify Unit of Dose UDI-DI: 04046964797972
- 4. Confirm description matches 130 in. IV admin set with 9 in. extension
- 5. If affected, discontinue use immediately
Where to find product info
Check the FDA enforcement page for Z-0692-2026 and the manufacturer’s recall notification for 490412.
What timeline to expect
No specific refund/replacement timeline provided. Typical recall remediation may take several weeks.
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- Escalate to hospital risk management if the supplier is slow to respond
- File a formal complaint with the U.S. FDA if necessary
How to prevent similar issues
- Verify catalog numbers and UDIs for all IV sets before deployment
- Purchase from approved suppliers and verify device labeling
- Ask manufacturers for clear recall timelines and replacement options
- Maintain an up-to-date recall registry for medical devices
- Inspect IV sets for unusual backflow indicators before use
Documentation advice
Keep the recall notice, labeling, UDIs, serials, and correspondence. Photograph packaging and labeling for records
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Product Details
Catalog Number: 490412 Primary UDI-DI: 04046964797989 Unit of Dose UDI-DI: 04046964797972 Description: 130 IN. IV ADMIN SET W/ 9 IN. EXT SET Sold worldwide including US, Canada, Germany, Guatemala, Singapore Quantity: 45,288 units Distribution: Worldwide distribution to US and international sites Expiration: Earliest Expiration of Component or up to 36 months Manufacturer: B. Braun Medical
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 130 in. IV set with 9 in. extension
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- Hazard: backflow and occlusion; no priming
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Safety Guide
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