B Braun Medical recalled over 49 million IV administration sets on October 29, 2025. The recall addresses a potential backflow of medication from secondary IV containers into primary IV containers. Users should stop using the affected devices immediately.
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 involves 49,330,370 IV administration sets with various catalog numbers. Products were distributed worldwide, including to the US, Canada, Germany, Guatemala, and Singapore.
These IV administration sets may allow medication to backflow from secondary containers into primary containers. This could compromise patient safety.
No specific incidents or injuries have been reported with this recall. The risk level has been classified as high due to the potential for medication misadministration.
Stop using the affected IV administration sets immediately. Follow the recall instructions provided by B Braun Medical. Contact your healthcare provider for further instructions.
For more details, visit B Braun Medical's website or call 1-800-XXX-XXXX. Additional information is available on the FDA's recall page.
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