B. Braun Medical recalled 126,050 IV administration sets used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The recall cites potential backflow from secondary to primary IV containers and an inability to prime. Health care providers and patients should stop using the device immediately and follow recall instructions from the manufacturer.
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 are used to deliver fluids and medication through IV lines. This recall concerns gravity and pump-assisted administration sets compatible with BBMI infusion pumps.
Backflow from piggyback containers into primary containers can misdeliver medication. Inability to prime increases risk of incorrect flow or no flow, potentially harming patients.
This recall is not described as part of a broader industry pattern in the summary provided.
Affected patients could experience incorrect dosing or interrupted therapy. The recall covers 126,050 units across multiple countries, highlighting a wide distribution.
Official recall notices and the FDA enforcement page list catalog numbers and UDIs. Check the manufacturer’s guidance for instructions on handling or returning products.
Recall processing timelines are not specified. Typically exchanges or replacements can take several weeks.
Preserve the recall letter, packaging, and any troubleshooting notes. Photograph labels and UDIs for reference.
Catalog Number: 354208. Primary UDI-DI: 04046964293818. Unit of Dose UDI-DI: 04046964293801. Expiration: Earliest Exp of Components or 24 months. Sold worldwide; US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Quantity: 126,050 units.
No injuries or incidents have been reported.
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