B. Braun Medical recalled 65,904 IV Administration Sets used with Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump. The recall cites backflow of medication from secondary (piggyback) IV containers into primary containers and an inability to prime. Hospitals should stop using the 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 deliver fluids and medications through IV lines, connecting bags to patients. They are used with gravity feeds and infusion pumps.
Backflow from a secondary (piggyback) container into the primary IV line can lead to unintended dosing. Inability to prime can cause incomplete delivery of medications.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics must identify affected stock, halt use, and coordinate refunds or replacements. Stock disruption could impact patient care during admissions or operations.
Official recall notice and instructions are on the FDA enforcement page for recall Z-0656-2026. Manufacturer communications will also provide details.
Refunds or replacements typically processed within 4-8 weeks after confirmation of affected inventory.
Keep the recall letter, inventory lists showing affected Catalog Number 490283, UDIs, and all correspondence with the manufacturer and distributors.
Catalog Number: 490283 Primary UDI-DI: 04046964716669 Unit of Dose UDI-DI: 04046964716652 Distribution: Worldwide US distribution and international distribution to Canada, Germany, Guatemala, and Singapore Quantity: 65,904 units Brand: B. Braun Medical Recall Date: 2025-10-29 Status: ACTIVE Hazard Level: HIGH Product: IV Administration Set used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump
No injuries or incidents have been reported.
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