B. Braun Medical IV Administration Set Recall for 1,250 Units Over Backflow Risk (2025)

How to identify if yours is affected

1. 1) Look for Catalog Number 352394 on packaging or device
2. 2) Verify Primary UDI-DI 4046964293375
3. 3) Confirm Unit of Dose UDI-DI 04046964293368
4. 4) Check for recall notice and instructions from B. Braun Medical

Where to find product info

FDA recall page and manufacturer notice; packaging labeling

What timeline to expect

Typically 4-8 weeks for refunds or replacements

If the manufacturer is unresponsive

• Document all communications with the manufacturer
• Escalate to hospital risk management or patient safety contacts
• File a consumer complaint with the FDA if necessary

How to prevent similar issues

• Verify UDI and catalog numbers before procurement
• Routinely review manufacturer recall notices for IV equipment
• Use infusion sets from trusted suppliers with clear recall histories

Documentation advice

Keep recall notice, product packaging, and correspondence; document serial numbers/UDI codes and dates of purchase; photograph labels.