6,768 IV administration sets are recalled worldwide by B Braun Medical. The recall covers devices used with gravity and pump systems. The hazard is potential backflow of medication into primary IV containers and inability to prime. Stop using the product and follow the recall instructions immediately. Contact B Braun Medical for instructions via the FDA recall page linked below.
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 medications via IV lines in clinical and facility settings. This recall involves gravity sets and pump-compatible sets used with BBraun Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
Backflow from secondary IV containers into primary containers can occur with this set. The occlusion issue can prevent proper priming, risking incorrect dosing or medication delivery.
This recall is not part of a broader industry pattern.
Hospitals and clinics may need to stop using affected lots and replace sets. The potential for incorrect dosing or contamination could affect patient safety and care delivery.
Product labeling and the FDA recall page linked in the article.
Refunds or replacements are not specified in the recall notice. Expect updates from the manufacturer; typical timelines for medical-device recalls can
Keep the recall letter, packaging photos showing Catalog Number and UDIs, and all correspondence with the manufacturer
Catalog Number: 490367 Primary UDI-DI: 04046964669903 Unit of Dose UDI-DI: 04046964669798 Sold worldwide (US, Canada, Germany, Guatemala, Singapore) Recall date: 2025-10-29 Quantity: 6,768 units Brand: B Braun Medical Product: IV Administration Set Price: Not disclosed
No injuries or incidents have been reported.
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