Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- B. Braun Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- 354204, 354205, 354206
- Sold at
- Unknown
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-enabled IV sets are used for gravity and pump-administered IV therapies. They are used in clinical settings to deliver medications intravenously with various pumps.
Why This Is Dangerous
Backflow from secondary IV containers into primary containers and failure to prime can lead to dosing errors or contamination of IV lines.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall aims to prevent medication backflow and occlusion issues that could affect patient safety and treatment efficacy in hospital settings.
Practical Guidance
How to identify if yours is affected
- Check catalog numbers on your IV sets: 354204, 354205, 354206.
- Cross-check with the recall notice on FDA enforcement page.
Where to find product info
Recall notice and device labeling contain UPC/UDI identifiers and catalog numbers.
What timeline to expect
Replacement or corrective action timelines typically align with manufacturer instructions and regulatory guidance; expect updates from BBraun Medical.
If the manufacturer is unresponsive
- Document all communications with BBraun Medical and healthcare facilities.
- File complaints with applicable regulatory authorities if the company is unresponsive.
How to prevent similar issues
- When purchasing infusion sets, confirm CARESITE components and verify UDI codes.
- Prefer suppliers with active recall notices and update safety information.
- Follow standard infection control and IV administration procedures to minimize risk.
Documentation advice
Keep copy of recall notice, take photos of product labels, retain purchase receipts if applicable, log all communications with the manufacturer and regulatory bodies.
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Product Details
Catalog Numbers: 354204, 354205, 354206 Primary UDI-DI: 04046964182075; Unit of Dose UDI-DI: 04046964182068 Catalog Numbers: 354205 Primary UDI-DI: 04046964182099; Unit of Dose UDI-DI: 04046964182082 Catalog Numbers: 354206 Primary UDI-DI: 04046964182112; Unit of Dose UDI-DI: 04046964182105 Distribution: Worldwide, including US and international distribution to Canada, Germany, Guatemala, and Singapore Sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- UDI-DI codes listed for each catalog number
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Safety Guide
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