B. Braun Medical recalled 554,015 SafeDAY IV administration sets distributed worldwide on Oct 29, 2025. The devices can backflow medication from secondary piggyback containers into primary IV containers and may fail to prime. Hospitals and clinics should stop using the affected sets and follow the manufacturer’s 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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SafeDAY sets are used to administer IV therapy in gravity and pump-driven systems. They are utilized with Infusomat Space Large Volume Pumps, Outlook Pump, and Vista Basic Pump.
Backflow from secondary to primary IV containers and occlusion can lead to incorrect dosing or interrupted therapy.
This recall is not described as part of a broader industry pattern in the provided data.
The recall affects more than half a million units; facilities must halt use to prevent potential medication backflow.
Recall notice via FDA enforcement portal and BBraun Medical communications.
4-8 weeks for refund or replacement processes once initiated by the manufacturer.
Keep recall letter, inventory lists, photos of labels, and all correspondence with the manufacturer
Catalog Number: 352646. Primary UDI-DI: 04046955626946. Unit of Dose UDI-DI: 04046955626939. Expiration Date: 36 months from Start Date. Distribution: Worldwide, including the US, Canada, Germany, Guatemala and Singapore. Quantity: 554,015 units.
No injuries or incidents have been reported.
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