B. Braun Medical recalls 11,650 extension sets used with Infusomat Space pumps sold worldwide after a backflow and priming defect. The device can allow medication to flow from a piggyback container into the primary line and may not prime properly. Hospitals 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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This extension set attaches to gravity IV administration lines and to pump administration sets in hospital settings. It is part of standard IV therapy equipment used by clinicians to deliver medications and fluids.
A backflow from piggyback containers into the primary IV line can occur and the system may fail to prime properly, risking incorrect dosing.
This recall is not part of a broader industry pattern.
Hospitals may need to remove affected extension sets from inventory and replace them. The recall could disrupt IV therapy in some care settings.
Serial numbers, date codes, and UPCs will appear on product labels and packaging as listed above
4-8 weeks for recall processing, depending on stock and logistics
Keep recall letter, take photos of product labels, save order receipts, and log all communications with manufacturer
Model numbers: AS152V2DLL; Catalog Number: 473309. Primary UDI-DI: 04046964299636. Unit of Dose UDI-DI: 04046964299629. Sold worldwide to US distribution and international markets including Canada, Germany, Guatemala, and Singapore. Sold date: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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