B Braun Medical Inc recalled 13,600 extension set units used with Infusomat Space and related pumps sold through multiple healthcare distributors worldwide. The recall cites a backflow risk from secondary piggyback containers into primary IV containers and an inability to prime due to occlusion. Healthcare providers and facilities should stop using the device immediately and follow manufacturer-re
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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The extension set connects IV lines from a primary infusion pump to the patient, allowing administration of IV medications. This particular product supports gravity IV and pump-assisted administration and uses a 57-inch Ultraport line.
Backflow from piggyback to primary IV containers can contaminate the IV line. An occlusion can prevent proper priming of the line, risking improper dosing.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics must halt use of the affected lots. The recall involves 13,600 units distributed worldwide, with potential for patient harm if not addressed promptly.
Labeling on the packaging and product documentation; recall notice and FDA page
Refund or replacement processing typically 4-6 weeks after verification
Save recall notification, take photos of labels, maintain shipment records and correspondence with the manufacturer
Catalog Number: 490202; Description: EXT SET W/ B/C VLV, ULTRAPORT, 57 IN.; Primary UDI-DI: 04046964303845; Unit of Dose UDI-DI: 04046964303838; Quantity recalled: 13,600 units; Regions distributed: Worldwide, including US, Canada, Germany, Guatemala, Singapore; Manufacturer: B Braun Medical Inc; Recall Date: 2025-10-29; Status: Active
No injuries or incidents have been reported.
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