B. Braun Medical recalled 33,528 Blood Administration Set units used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The sets have a backflow risk from secondary piggyback IV containers into primary IV containers and may fail to prime. Health-care facilities should stop using the device immediately and follow the recall letter 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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Blood administration sets are used to administer blood via gravity or pump systems. This recall concerns a Y-Type Blood Set used with Infusomat Space Large Volume Pumps and related pump systems.
The defect can cause backflow from a secondary IV container into the primary container and may prevent proper priming, creating a potential for incorrect dosing or infusion errors.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics may need to replace the affected sets to maintain patient safety. No injuries are reported in the data provided.
Recall letter from B. Braun Medical; FDA enforcement page for Z-0618-2026
Refund or replacement typically 4-8 weeks
Retain recall notice, model numbers, UDI codes, purchase records, and all correspondence with the manufacturer.
Catalog Number: 490530; Primary UDI-DI: 04046955203321; Unit of Dose UDI-DI: 04046955203314; Distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore); Quantity: 33,528 units.
No injuries or incidents have been reported.
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