B Braun Medical Inc recalled 1,019 IV administration sets worldwide after reports of backflow and occlusion. The devices were used with BBMI Infusomat Space, Outlook, and Vista Basic pumps. The recall affects a single catalog number 457506 with UDI details. Patients should stop using the device and follow manufacturer instructions for return.
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 enable IV drug delivery via gravity or pump systems. They connect the IV bag to the patient and may include piggyback configurations.
Backflow from secondary to primary IV containers can lead to unintended dosing and contamination. Occlusion prevents proper priming of the line.
This recall is not described as part of a broader pattern in the provided data.
High risk to patients if backflow occurs or priming fails, potential for incorrect dosing or interrupted therapy.
UDI and catalog numbers are on labeling; contact manufacturer for recall specifics.
The recall was announced by FDA enforcement with notice dated 2025-12-03; timelines for refunds or replacements are per manufacturer instructions.
Keep recall letter, packaging, device labeling, and all correspondence with manufacturer.
Catalog Number: 457506. Primary UDI-DI: 04046964716126. Unit of Dose UDI-DI: 04046964716119. Sold worldwide including US, Canada, Germany, Guatemala, Singapore. Quantity: 1,019 units. Brand: B Braun Medical Inc. Related pumps: BBMI Infusomat Space Large Volume Pump, Outlook Pump, Vista Basic Pump.
No injuries or incidents have been reported in the document provided.
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