BBraun Medical recalled 23,160 IV administration sets distributed worldwide, including the US and Canada, after reports of backflow and occlusion risk. The recall involves catalog number 490487 and UDIs 04046955086856 and 04046955086849. Stop using the product immediately and follow manufacturer instructions for recall procedures.
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 medications via IV lines. They connect to IV bags or containers and may be used with gravity or pump-driven systems.
Backflow into primary containers or occlusion can disrupt dosing and advance the risk of medication errors or incomplete infusion.
This recall is not described as part of a broader industry pattern in the notice.
The risk is significant for clinical accuracy and patient safety. Hospitals will need to remove affected inventory and coordinate replacements.
Refer to the FDA enforcement recall page linked in the notice for detailed instructions and refunds.
4-8 weeks for refunds or replacements typical.
Keep the recall notice, product packaging, model numbers, UDIs, and all correspondence with the manufacturer for records.
Catalog Number: 490487 Primary UDI-DI: 04046955086856 Unit of Dose UDI-DI: 04046955086849 Quantity recalled: 23,160 units Sold worldwide, including US, Canada, Germany, Guatemala, Singapore Recall date: 2025-10-29 Status: ACTIVE Brand: B Braun Medical Product: IV Administration Set used in gravity and pump administration with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump
No injuries or incidents have been reported.
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