B. Braun Medical recalled 49,330,370 Infusomat IV sets worldwide after a potential backflow from secondary to primary IV containers and an inability to prime. The recall covers gravity IV sets and pump sets used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Stop using any affected sets immediately and contact B. Braun Medical for instructions on refunds or replacement
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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Infusion sets enable IV medications to be delivered from a bag or bottle into a patient’s vein. They are used with both gravity and pump-assisted IV systems.
Backflow from a secondary IV container into the primary line can lead to incorrect medication dosing. An occlusion can prevent proper priming of the line, risking under- or over-infusion.
This recall is not part of a broader industry pattern.
Healthcare providers and patients could face delays or interruptions in IV therapy if an affected set is in use. The recall could drive replacement costs and require reeducation on IV administration.
Recall details available on FDA enforcement page and the manufacturer’s notice.
Refunds or replacements typically take 4-8 weeks.
Keep the recall notice, purchase receipts, and all correspondence. Photograph affected packaging and catalog numbers for records.
Catalog Numbers: 362032, 362033, 362034, 362043, 362050, 362420, 362431, 362432, 363010, 363019, 363030, 363230, 363419, 363420, 363421, 363422, 363423, 363424, 363430, 363433, 480254, 480255, 480256, 480258, 480263, 490100, 490101. Distribution: Worldwide distribution including US and international markets such as Canada, Germany, Guatemala, and Singapore. Classification: Class II recall. Quantity: 49,330,370 units. Reason: Potential backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Remedy: Stop using the产品.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
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