B. Braun Medical's 490238 Extension Set, used with Infusomat Space Large Volume Pumps and other BBMI devices, is recalled worldwide to hospitals and clinics. The device can allow backflow from secondary piggyback IV containers into the primary container and cannot be primed. Healthcare facilities should stop using the device immediately and follow the manufacturer's 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 extension sets connect piggyback IV containers to the primary IV line. They are used in hospital and clinical settings to administer fluids and medications.
Backflow from secondary to primary IV lines and inability to prime can affect IV therapy safety and effectiveness.
This recall is not part of a broader industry pattern.
Hospitals may need to quarantine affected lots and adjust IV administration workflows. The recall could impact supply chains for IV fluids and medications.
FDA enforcement report and the manufacturer's recall notices.
Remedy processing timelines typically 4-6 weeks for replacement or refund, but patient impact may vary by facility.
Keep recall notices, packaging images, catalog numbers, and all correspondence. Capture photos of affected units and note UDI codes.
Catalog Number: 490238 Primary UDI-DI: 04046964716409 Unit of Dose UDI-DI: 04046964716393 Description: EXT SET W/ 6 B/C VALVES, 17 IN Sold worldwide: US distribution and international distribution to Canada, Germany, Guatemala, and Singapore Price: Unknown When sold: Unknown
No injuries or incidents have been reported.
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