B. Braun Medical Inc. is recalling 65,232 IV administration sets used with Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump worldwide. The devices pose a risk of backflow from secondary piggyback IV containers into primary IV containers and may fail to prime due to occlusion. Hospitals and healthcare providers should stop using the affected sets immediately and follow the maker
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 through gravity or pump-assisted IV systems in clinical settings.
Backflow from piggyback to primary IV containers and occlusion can disrupt accurate medication delivery and patient safety.
This recall is not described as part of a broader industry pattern.
Hospitals may experience workflow disruption and potential patient safety risk if affected sets remain in use.
Recall notice and FDA enforcement page; manufacturer correspondence will list next steps.
Timeline for refunds or replacements is not specified in the recall notice.
Keep the recall notice, serials, UDIs, and all correspondence with the manufacturer.
Catalog Numbers: 490549 and 490565. Primary UDI-DI: 04046955270323 and 04046955275601. Unit of Dose UDI-DI: 04046955270316 and 04046955275595. Expiration: Earliest Expiration of Component or 36 months. Distribution: Worldwide, including US and international distribution to Canada, Germany, Guatemala, and Singapore. Sold through healthcare distributors and hospital systems. Recall date: 2025-10-29. Report date: 2025-12-03. Units recalled: 65,232. Brand: B. Braun Medical Inc.
No injuries or incidents have been reported.
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