B Braun Medical Inc. recalled 32,436 Anesthesia IV Sets used with Infusomat Space, Outlook Pump, and Vista Basic Pump after reports of backflow risk and occlusion. The recall covers catalog numbers 490189 and 490226 distributed worldwide, including the US, Canada, Germany, Guatemala and Singapore. Consumers should stop using the device immediately and follow manufacturer instructions for recall. A
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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These IV sets are used to deliver medications through gravity or pump-assisted IV systems in clinical settings.
Backflow can allow medication from a piggyback container to flow into the primary container, potentially delivering a higher concentration or contamination. Occlusion can prevent proper priming of the line, disrupting flow.
This recall is not described as part of a broader pattern in the data.
Healthcare facilities may need to halt use of affected IV sets, potentially disrupting workflows and requiring replacements.
UDI codes are printed on the packaging and on device labels.
Remedy delivery and replacement timelines not specified; expect recall follow-up communications.
Keep recall notice, shipment receipts, and correspondence with manufacturer and healthcare providers.
Brand: B Braun Medical. Product: Anesthesia IV Set used with gravity and pump administration sets. Catalog numbers: 490189 (IV ADMIN SET W/15 DROPS/ML, 108 IN) and 490226 (IV ADMIN SET 137 IN). Primary UDI-DI: 04046964303586 (490189) with Unit of Use 04046964303579; Primary UDI-DI: 04046964304262 (490226) with Unit of Use 04046964304255. Sold worldwide with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Recall date: 2025-10-29. Status: ACTIVE.
No injuries or incidents have been reported.
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