B. Braun Medical Inc. recalled 5,952 IV Administration Sets distributed worldwide, including the US, Canada, Germany, Guatemala and Singapore, for use with Infusomat Space, Outlook, and Vista Basic Pumps. The units carry Catalog Number 490612. The recall cites potential backflow from secondary piggyback IV containers into primary containers and an inability to prime. Hospitals and healthcare teams
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 from a reservoir to a patient via gravity or pump-assisted systems. This recall concerns a piggyback configuration used with several BBraun infusion pumps and related components.
Backflow from secondary containers into primary IV lines could result in incorrect dosing or contamination. Inability to prime can lead to under-delivery of fluids or medications.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics may need to halt use, quarantine affected lots, and replace with safe alternatives. The recall could affect patient monitoring and drug administration workflows.
FDA enforcement page for Z-0677-2026 and the manufacturer's recall notice
4-8 weeks for replacement or refund after processing
Keep recall notices, packaging, delivery receipts, and correspondence with the manufacturer. Photograph affected serial numbers and UDIs for records.
Catalog Number: 490612; Primary UDI-DI: 04046955664610; Unit of Dose UDI-DI: 04046955664603; Expiration Date: Earliest Expiration of Component or 36 months; Sold Worldwide including US, Canada, Germany, Guatemala, Singapore; Recall Date: 2025-10-29; Quantity: 5,952 units; Brand: B. Braun Medical; Used with: Infusomat Space Large Volume Pump, Outlook Pump, Vista Basic Pump
No injuries or incidents have been reported.
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