B. Braun Medical recalled 46,250 SAFELINE IV sets sold worldwide on Oct. 29, 2025. The devices pose a backflow risk from secondary piggyback IV containers into primary lines and may fail to prime due to occlusion. Hospitals and patients using Infusomat Space Large Volume Pump, Outlook Pump, or Vista Basic Pump with SAFELINE sets should stop use immediately and await 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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SAFELINE sets are used in gravity IV administration and pump administration with infusion pumps in healthcare settings.
Backflow of medication from secondary piggyback containers into primary IV lines can cause dosing errors or contamination. Occlusion can prevent priming.
This recall is not part of a broader industry pattern.
Hospitals may need to switch to alternate IV sets; potential workflow disruption and patient safety risks if used.
Identifiers appear on packaging and device labels, including catalog numbers and UDIs.
Not specified by the recall notice.
Keep recall notice, photos of labels, purchase documents, and correspondence.
Catalog Numbers: 352604; NF1251; NF1290. Primary UDI-DI: 04046964181870; 04046964187100; 04046964187148. Unit of Dose UDI-DI: 04046964181863; 04046964187094; 04046964187131. Expiration: Earliest Exp of Component or 60 months. Sold Worldwide with US distribution and distribution to Canada, Germany, Guatemala, and Singapore. Quantity: 46,250 units. Brand: B. Braun Medical. Recall Date: 2025-10-29. Recall Number: Z-0713-2026. Status: Active.
No injuries or incidents have been reported.
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