B Braun Medical recalled 11,832 IV administration sets worldwide on Oct 29, 2025. The devices are used with Infusomat Space, Outlook, and Vista Basic Pumps. The hazard is backflow of medication and occlusion. Stop using the product immediately and follow manufacturer recall instructions. Check your model numbers and contact the manufacturer for refunds or replacements.
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 are used to deliver fluids and medications in clinical settings. This recall involves sets used with gravity and pump infusion systems.
The defect can allow backflow from piggyback containers into the primary IV line and may prevent proper priming due to occlusion, risking incorrect dosing or contamination.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics may need to substitute sets quickly to avoid treatment delays. Consumers could face delays in care if replacements are not readily available.
Product identifiers are printed on the packaging and on the IV set itself.
Refunds/replacements follow the manufacturer’s recall process. Processing times vary by supplier.
Keep the recall notice, purchase receipts, serial numbers/CDs, photos of the product, and any correspondence with the manufacturer.
Catalog Numbers: 490315, 490331, 490376. Worldwide distribution including US and international distribution to Canada, Germany, Guatemala, and Singapore. Sold: Unknown. Recall date: 2025-10-29. Quantity: 11,832 units. Price: Unknown. US/International distribution: Yes. Model numbers and related UDIs: - Catalog Number 490315. Primary UDI-DI: 04046964527173. Unit of Dose UDI-DI: 04046964525612. - Catalog Number 490331. Primary UDI-DI: 04046964541148. Unit of Dose UDI-DI: 04046964541131. - Catalog Number 490376. Primary UDI-DI: 04046964718182. Unit of Dose UDI-DI: 04046964718175.
No injuries or incidents have been reported.
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