B Braun Medical recalled 45,288 IV administration sets on October 29, 2025. The recall addresses a risk of backflow from secondary IV containers into primary containers. Users must stop using the product immediately and follow manufacturer 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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The recalled IV administration set includes the model labeled as Catalog Number 490412. It is designed for use with B Braun's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Products were distributed worldwide including the US, Canada, Germany, Guatemala, and Singapore.
The recall was initiated due to the potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers. This could lead to medication errors and ineffective treatment.
No specific incidents of injury or death have been reported as a result of this issue. The hazard level is classified as high due to the potential for serious medication errors.
Stop using the IV administration set immediately. Follow the recall instructions provided by B Braun Medical Inc. For further assistance, contact your healthcare provider or B Braun Medical.
For more information, contact B Braun Medical Inc at the provided website link. Visit: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0692-2026.
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