BBraun Medical recalled 5,448 Blood Administration Sets used with Infusomat Space pumps worldwide sold to hospitals. The recall cites potential backflow of medication from secondary piggyback IV containers into primary IV containers and an inability to prime. Healthcare facilities should stop using the sets immediately and follow recall instructions from B. Braun Medical.
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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Blood administration sets are used to deliver blood products and IV fluids in hospitals. They connect to pumps or gravity feeds for controlled infusion.
Backflow from secondary to primary IV containers and failure to prime can lead to misdelivery of medications or volume errors.
This recall is not indicated as part of a broader industry pattern.
Hospitals may need to halt use and replace inventory, which can affect patient care workflow and supply management.
Recall notification letter and FDA enforcement page linked in the recall notice.
4-6 weeks for processing and refunds/replacements where applicable.
Keep the recall letter, inventory lists, and correspondence with the supplier; photograph packaging and catalog labels for records.
Catalog Number: 480233. Primary UDI-DI: 04046955083572. Unit of Dose UDI-DI: 04046955083565. Sold worldwide, including US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Sold since: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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