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, 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: 354211, Primary UDI-DI: 04046964182198, Unit of Dose UDI-DI: 04046964182181
- 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 connect IV bags to patients to deliver fluids and medications either by gravity or via infusion pumps. They are used widely in hospitals and clinics.
Why This Is Dangerous
Backflow from a secondary IV container into the primary container can alter the dose delivered. Inability to prime can lead to incomplete delivery of the prescribed medication.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Healthcare facilities may need to replace affected sets. The recall affects 286,400 units worldwide, potentially causing operational delays and procurement adjustments.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 354211 on the device label
- Verify Primary UDI-DI 04046964182198
- Verify Unit of Dose UDI-DI 04046964182181
- Confirm expiration date on packaging
Where to find product info
On device label and packaging; recall notice from FDA and manufacturer
What timeline to expect
Remedy processing commonly 4-6 weeks after submission
If the manufacturer is unresponsive
- Escalate with hospital recall coordinator
- File a report with the FDA recall page
- Consult your procurement department
How to prevent similar issues
- Verify backflow-prevention features for IV sets
- Cross-check product labels with UDI data before purchasing
- Establish recall monitoring with suppliers
- Maintain up-to-date supplier recall lists
Documentation advice
Preserve recall notice; Photograph catalog numbers and UDI codes; Save all correspondence and replacement receipts
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Product Details
Catalog Number: 354211 Primary UDI-DI: 04046964182198 Unit of Dose UDI-DI: 04046964182181 Description: IV ADM 15 DROP W/3 CARESITE N/C DUAL Quantity: 286,400 units Distribution: Worldwide; US distribution and international distribution to Canada, Germany, Guatemala and Singapore Expiration: Earliest Expiration of Component or 24 months Sold at: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964182181
- Distribution worldwide (US, Canada, Germany, Guatemala, Singapore)
- Expiration: Earliest Exp of Comp or 24 months
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Safety Guide
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