BBMI recalled 63,192 IV administration sets worldwide on Oct 29, 2025. The recall affects the IV administration set labeled as 490426 with UDIs listed. The defect is potential backflow from secondary to primary IV containers and an inability to prime. Patients and healthcare providers should stop using these devices immediately and follow the manufacturer’s recall 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 are tubing assemblies used to deliver medications and fluids via IV and piggyback systems. They connect to pumps or gravity-fed IV lines to deliver controlled doses.
Backflow could cause incorrect dosing or contamination. Occlusion may prevent proper priming and flow.
This recall is not noted as part of a broader industry pattern in the provided data.
The recall involves a large quantity and worldwide distribution, emphasizing immediate discontinuation and replacement through manufacturer guidance.
FDA enforcement page Z-0681-2026 and BB Braun Medical recall communications
Typical recall timelines range from weeks to months for replacement or refund; exact timeframe not provided
Keep recall letters, UDIs, catalog numbers, purchase records, and correspondence with the manufacturer
Model: Catalog Number 490426. Primary UDI-DI: 04046964823503. Unit of Dose UDI-DI: 04046964823497. Expiration: Earliest Expiration Date of Component or 36 months. Quantity: 63,192 units. Distribution: Worldwide including US, Canada, Germany, Guatemala, Singapore. Brand: B Braun Medical. Product: IV Administration Set used with gravity and pump administration sets for BBMI Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
No specific injuries or incidents are detailed in the provided data.
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