B. Braun Medical recalled 150,664 Rate Flow IV Sets used with Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump. The devices are cataloged as 375258. The recall addresses a potential backflow from piggyback IV containers into primary containers and an inability to prime. Hospitals and healthcare providers should stop using the device immediately and follow the manufacturer’s rec
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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Rate Flow IV Sets are used to deliver intravenous solutions either by gravity or through infusion pumps in healthcare settings. They connect to IV containers and allow controlled flow into patients.
Backflow from secondary to primary IV containers may occur, risking unintended dosing or contamination. Inability to prime increases risk of under-infusion or occlusion.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals and clinics may need to replace affected sets promptly to prevent potential medication backflow and priming failures, affecting patient care operations and budgets.
UDI-DI and catalog numbers are typically printed on the tubing set packaging and on the device label.
Refunds or replacements are typically processed within 4-6 weeks after verification.
Keep the recall notice, supplier correspondence, and replacement records. Photograph catalog numbers and UDIs for proof.
Catalog Number: 375258; Primary UDI-DI: 04046955256976; Unit of Dose UDI-DI: 04046955256969; Expiration Date: Earliest Exp of Component or 36 months; Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore; Quantity: 150,664 units; Sold distribution: Worldwide to hospitals and healthcare facilities.
No injuries or incidents have been reported.
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