B. Braun Medical Outlook IV Set Recall 18,072 Units for Backflow Risk (2025)

How to identify if yours is affected

1. Check catalog number 354213 on the device or packaging.
2. Check Primary UDI-DI 04046964182211 and Unit of Dose UDI-DI 04046964182204.
3. Confirm expiration date is the earliest expiry of comp or within 36 months.

Where to find product info

Identifiers are labeled on the product packaging and documentation. FDA recall page lists recall Z-0707-2026.

What timeline to expect

Replacement or recall processing typically takes 4-6 weeks after confirmation.

If the manufacturer is unresponsive

• Document all attempts to contact the manufacturer, escalate to hospital risk management, contact FDA for guidance on recalls.
• Consider filing a complaint with regulatory authorities if the company is unresponsive.

How to prevent similar issues

• Verify UDI-DI labels before acquiring IV sets.
• Maintain a record of recall notices from the regulatory database.
• Establish a recall review process in healthcare procurement to rapidly identify affected lots.

Documentation advice

Keep the recall notice, take photos of catalog numbers and labels, save all correspondence, and track refunds or replacements.