B Braun Medical Inc. recalls 5,100 IV administration sets distributed worldwide, including the US, Canada, Germany, Guatemala and Singapore. The recall cites backflow of medication from piggyback containers into primary IV containers and an occlusion that prevents priming. Patients should stop use immediately and follow 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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IV administration sets are used to deliver fluids and medications via intravenous tubing. These sets connect to IV bags or bottles and may be used with automated pumps.
Backflow can cause unintended dosing or contamination. Occlusion can prevent proper priming, risking under-delivery or over-delivery of medications.
This recall is not part of a broader industry pattern; it highlights specific device-set compatibility and backflow/occlusion risks.
High risk for incorrect dosing and potential contamination if backflow occurs. Timely replacement is essential to maintain safe IV administration.
UDI labels and catalog numbers on the packaging and on the IV set tubing itself.
Replacement or refund timeline to be provided by BBraun Medical Inc; expect weeks to months depending on stock and process.
Keep recall notice, photos of product, purchase receipts, and correspondence with manufacturer.
Catalog Number: 490239. Primary UDI-DI: 04046964716423. Unit of Dose UDI-DI: 04046964716416. Expiration: earliest expiration of component or 24 months. Quantity: 5,100 units. Distribution: Worldwide including US, Canada, Germany, Guatemala, Singapore.
No specific injuries or incidents are mentioned in the provided data. The status is active and hazard level HIGH.
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