B Braun Medical recalled 1,200 IV extension sets on October 29, 2025. The recall stems from a risk of medication backflow from secondary IV containers into primary containers. The affected model is catalog number 490358.
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 recall affects IV extension sets identified by catalog number 490358. These were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.
The extension set poses a high risk of backflow of medication from secondary IV containers into primary IV containers. This could compromise patient safety and lead to serious health consequences.
No specific incidents or injuries have been reported at this time, but the potential for serious harm exists.
Stop using the extension set immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions. Follow the recall instructions provided in the notification letter.
For more information, contact B Braun Medical at their official website or via phone. Visit the FDA's recall page for additional details.
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