B. Braun Medical recalled 259,392 IV administration sets worldwide on Oct. 29, 2025. The devices could allow backflow of medication from secondary (piggyback) IV containers into primary IV containers and may not prime due to occlusion. Hospitals and healthcare providers should stop using the device immediately and follow recall instructions in the notice.
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 through IV lines in hospital and clinical settings. This recall covers a gravity and pump-compatible set used with BBMI pumps such as Infusomat Space, Outlook, and Vista Basic. The affected units were distributed worldwide.
Backflow from secondary (piggyback) IV containers into primary containers can cause dosing errors. Occlusion can prevent proper priming, stopping flow and delivery of medications.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics rely on IV sets for accurate medication delivery. The issue could lead to incorrect dosing or interrupted infusion, potentially compromising patient safety and treatment efficacy.
UDI-DI on label, package, and associated recall notices; recall URL in FDA enforcement page.
Not specified in recall.
Keep the recall notification letter, packaging photos, catalog numbers, and UDIs; record dates of contact and responses.
Catalog Number: 490309; Primary UDI-DI: 04046964527517; Unit of Dose UDI-DI: 04046964527500. Sold worldwide including US, Canada, Germany, Guatemala, Singapore. Price: Unknown. Sold since: Unknown.
No injuries or incidents have been reported.
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