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
- Intravenous (IV) administration set
- Model numbers
- Catalog Number: 354207, Primary UDI-DI: 04046964182136, Unit of Dose UDI-DI: 04046964182129
- 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
CareSite injection sites are used in gravity IV sets and pump administration sets for IV therapy. They connect to IV lines and are used in hospital settings with infusion pumps.
Why This Is Dangerous
The defect allows backflow from secondary IV containers into the primary IV container and may prevent priming, potentially affecting dosing accuracy.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt use of affected IV sets and implement replacements. A recall of 381,850 units implies substantial procurement and workflow impact.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 354207 on the product packaging labeling.
- Check Primary UDI-DI 04046964182136 and Unit of Dose UDI-DI 04046964182129 on the product labeling.
- If affected, stop using immediately.
Where to find product info
Recall details and instructions are available on the FDA enforcement page linked in the recall notice.
What timeline to expect
Refund or replacement processing typically takes 4-6 weeks after a claim is submitted.
If the manufacturer is unresponsive
- Escalate to hospital purchasing or risk management.
- File a consumer complaint with FDA if the manufacturer is unresponsive.
How to prevent similar issues
- Verify UDI codes on incoming inventory.
- Source IV administration sets from authorized distributors.
- Maintain a recall monitoring process for medical devices used in IV therapy.
Documentation advice
Document recall notice, catalog number, and UDI numbers. Save correspondence with the supplier and any replacement orders.
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Product Details
Catalog Number: 354207. Primary UDI-DI: 04046964182136. Unit of Dose UDI-DI: 04046964182129. Distribution: Worldwide, including US, Canada, Germany, Guatemala and Singapore. Sold by B. Braun Medical. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964182129
- Worldwide distribution (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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