BBraun Medical Inc. recalled 104,784 Anesthesia IV Sets used with Infusomat Space, Outlook, and Vista Basic pumps. The recall cites backflow of medication from secondary to primary IV containers and a potential inability to prime. Health care providers should stop using the devices immediately and follow the manufacturer’s recall instructions for refund 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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IV admin sets deliver medications or fluids during medical procedures. This recall concerns piggyback setups in gravity or pump-assisted lines.
Backflow can lead to misdose or contamination and line occlusion can interrupt infusion, potentially impacting patient safety.
This recall is not described as part of a broader industry pattern in the provided data.
Immediate action required in clinical settings. Utilities and refunds may take weeks; patient safety depends on stopping use and replacing with approved sets.
UDI labels on packaging and device labeling; recall notice on FDA enforcement page.
Refunds or replacements are issued per manufacturer directions; typical processing spans several weeks.
Keep packaging labels, UDIs, recall notices, and correspondence with BBraun Medical.
Catalog Numbers: 490469 and 490470. Description: IV Admin Set with 15 drops/mL, 132 in; 60D 2 CARESITE VLV, 132 in. Primary UDI-DI: 04046964958816; Unit of Dose UDI-DI: 04046964958809. Secondary Catalog Number: 490470; Primary UDI-DI: 04046964958830; Unit of Dose UDI-DI: 04046964958823. Sold worldwide including US, Canada, Germany, Guatemala, Singapore.
No specific incident counts are provided in the recall notice. The FDA enforcement page lists the hazard and quantity but does not enumerate injuries or incidents.
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