B Braun Medical recalls 12,168 IV administration sets used with Infusomat Space, Outlook, and Vista Basic pumps. The backflow of medication from secondary to primary containers and the inability to prime pose a high-risk issue. Stop using the device immediately and follow manufacturer 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 deliver fluids and medications via gravity or pump-based systems in hospital and clinical settings.
Backflow into primary IV containers and occlusion could lead to incorrect dosing or interrupted therapy, posing patient safety risks.
This recall is not described as part of a broader industry pattern.
Healthcare facilities may need to halt use of affected sets and initiate replacements or refunds, with potential operational disruption.
Labeling and packaging contain UDI codes; recall page provides guidance.
4-6 weeks for refunds or replacements in typical recalls.
Retain recall notice, packing labels, and correspondence for records.
Catalog Number: 490511 Primary UDI-DI: 04046955135875 Unit of Dose UDI-DI: 04046955135868 Description: IV ADMIN SET W/ 15 DROPS/ML Sold worldwide including US, Canada, Germany, Guatemala, Singapore Quantity: 12,168 units Expiration: Earliest Expiration of Component or 36 months Additional info: Distributed worldwide; labeled with catalog and UDI numbers.
No injuries or incidents have been reported.
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