B Braun Medical Inc. recalls 36,936 IV administration sets used with Infusomat Space and other pumps worldwide. The recall was announced Oct. 29, 2025 and includes US and international distribution to Canada, Germany, Guatemala and Singapore. The devices may allow backflow of medication from secondary containers into the primary container and cannot be primed. Stop using immediately and follow the
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 medications and fluids through IV lines, either by gravity or with infusion pumps. This recall concerns a gravity/pump-compatible set labeled 490504.
Backflow can deliver medications into incorrect containers or cause contamination. An occlusion can prevent priming, compromising safe administration and delivery of fluids.
This recall is not described as part of a broader industry pattern.
Hospitals and caregivers may need to switch to other IV sets. The recall emphasizes immediate cessation of use and reliance on manufacturer guidance.
UDI-DI numbers and Catalog Number are on device labeling and packaging.
4-6 weeks for replacement or remedy processing or guidance from the manufacturer.
Keep copies of all recall notices, device labels, UDIs, and correspondence with the manufacturer.
Catalog Number: 490504. Primary UDI-DI: 04046955135738. Unit of Dose UDI-DI: 04046955135721. Sold worldwide including the US, Canada, Germany, Guatemala and Singapore. Sold from unknown date to unknown date. Price: Unknown.
No injuries or incidents have been reported.
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