B. Braun Medical recalled 1,250 IV administration sets distributed worldwide to hospitals and clinics. The devices may allow backflow of medication from secondary (piggyback) IV containers into primary containers and may not prime properly. Hospitals and other healthcare providers should stop using the devices immediately and follow recall instructions.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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
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IV administration sets connect IV bags to patients and can be used with gravity drip systems or syringe/roller pumps. This recall covers a specific ULTRASITE set used with several BBMI pumps.
Backflow from secondary to primary IV containers can alter dosing and may prevent proper priming of the line, posing patient safety risks.
This recall is not part of a broader industry pattern.
Hospitals may need to pause using affected IV sets and source replacements, which could affect infusion workflows and patient care timelines.
FDA recall page and manufacturer notice; packaging labeling
Typically 4-8 weeks for refunds or replacements
Keep recall notice, product packaging, and correspondence; document serial numbers/UDI codes and dates of purchase; photograph labels.
Catalog Number: 352394 Primary UDI-DI: 4046964293375 Unit of Dose UDI-DI: 04046964293368 Quantity: 1,250 units Distribution: Worldwide distribution to US, Canada, Germany, Guatemala, and Singapore Recall Date: 2025-10-29 Manufacturer: B. Braun Medical Model/Line: ULTRASITE IV ADMIN SET 60DROP Price: Unknown
No injuries or incidents have been reported.
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