B. Braun Medical recalled 27,480 extension sets used with Infusomat Space Large Volume Pump and related pumps after identifying a backflow and priming risk. The catalog number is 490234 and the primary UDI-DI is 04046964716362. The recall is active worldwide as of 2025-12-03.
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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This extension set attaches to gravity IV administration sets or pump administration sets used with BBMI infusion pumps. It is intended to deliver medications and fluids from IV bags to patients.
Backflow from secondary IV containers into primary containers can occur due to design issues. The device may also fail to prime, potentially impacting dose delivery.
This recall is not stated as part of a broader industry pattern in the provided data.
Healthcare facilities may need to inspect inventory and remove affected lots. Hospitals could face downtime to replace the device and adjust infusion workflows.
Recall details and identifiers are on the FDA enforcement page and the manufacturer’s recall notice
Remedies, refunds, or replacements typically take 4-6 weeks
Keep recall notice, photos of the product, batch numbers, and all correspondence with the manufacturer
Catalog Number: 490234. Primary UDI-DI: 04046964716362. Unit of Dose UDI-DI: 04046964716355. Sold worldwide with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Quantity: 27,480 units. Brand: B. Braun Medical.
No injuries or incidents have been reported.
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