B. Braun Medical Inc. recalled 9,500 IV administration sets with worldwide distribution including the United States, Canada, Germany, Guatemala and Singapore. The devices may backflow medication from secondary piggyback IV containers into primary IV containers and may fail to prime. Hospitals and healthcare providers should stop using the device immediately and follow the manufacturer's recall’s,[
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 in hospitals and clinics. They connect to IV bags or containers and may be used with gravity or infusion pumps.
Backflow from piggyback containers into primary containers and failure to prime can lead to incorrect dosing or interrupted IV therapy.
This recall is not described as part of a broader industry pattern.
Facilities must identify affected lots, halt use, and replace or manage inventory to avoid patient safety risks. No injuries have been reported yet.
Review labeling on device and the FDA recall page linked in the notice.
Not specified by recall; follow manufacturer instructions for replacement or disposal.
Keep copy of recall notice, photos of labels, UDI numbers, and all correspondence with the manufacturer.
Catalog Number: 490070 Primary UDI-DI: 04046964301582 Unit of Dose UDI-DI: 04046964301575 Description: IV Administration Set used in gravity IV administration sets and pump administration sets for Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump Sold distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore) Recall Date: 2025-10-29 Status: Active Quantity: 9,500 units Price: Unknown
No injuries or incidents have been reported.
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