B. Braun Medical Inc. is recalling 12,320 burette sets worldwide used with Infusomat Space, Outlook Pump, and Vista Basic Pump. The device can allow backflow from secondary IV containers into primary containers and may fail to prime. Hospitals and clinics should stop using the device immediately and follow the 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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Burette sets are used to deliver precise volumes of IV medication in hospital settings. They are connected to gravity or pump-based IV systems to regulate dosing.
Backflow can cause medication to move from secondary containers into primary ones, delivering incorrect dosages. Occlusion can prevent priming, disrupting IV therapy delivery.
This recall is not stated as part of a broader industry pattern.
Hospitals may need to halt certain IV delivery workflows. Replacement devices may be required to resume therapy without delay.
Identifiers are on the device label and packaging. Recall notices explain the affected lot or unit identifiers.
Recall notifications by letter are issued. Replacements or remediation guidance will follow from the manufacturer. Typical processing times may vary,
Keep the recall letter, print or save the official recall page, take photos of labels, and log all correspondence with the manufacturer.
Catalog Number: 490252; Primary UDI-DI: 04046955545636; Unit of Dose UDI-DI: 04046955545629; Quantity: 12,320 units; Distribution: Worldwide (US and international to Canada, Germany, Guatemala, and Singapore).
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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