B Braun Medical recalled 19,392 anesthesia IV sets on October 29, 2025 due to the potential for medication backflow. The defective sets may cause occlusion and were sold worldwide, including in the US, Canada, Germany, Guatemala, and Singapore.
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 anesthesia IV sets are labeled under Catalog Number 490452. These sets were part of gravity IV administration systems and pump administration sets, including the Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
The recall stems from a potential for backflow of medication from secondary IV containers into primary IV containers. This backflow can lead to medication errors and serious health risks.
As of now, there are no reported incidents or injuries directly linked to the recalled IV sets. However, the potential for serious complications necessitates immediate action.
Stop using the recalled anesthesia IV sets immediately. Follow the specific recall instructions provided by the manufacturer and contact B Braun Medical Inc or your healthcare provider for further guidance.
For more information, contact B Braun Medical Inc at their official website or call the customer service line. Additional details are available on the FDA website.
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