B Braun Medical recalled 23,160 IV administration sets on October 29, 2025. The sets pose a high risk of medication backflow from secondary containers into primary containers. Healthcare providers should stop using the 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 recalled product is the IV Administration Set, catalog number 490487. It was distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore. The sets were sold as part of gravity IV administration sets and pump administration sets.
The IV administration sets have a potential risk of backflow of medication from piggyback IV containers into primary IV containers. This issue can lead to serious medication errors and complications for patients.
No specific incidents or injuries related to this recall have been reported. The recall was issued due to the identified risk, not as a result of reported injuries.
Patients and healthcare providers should stop using the IV administration sets immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions. Follow the recall instructions provided by the manufacturer.
For more information, contact B Braun Medical Inc at their customer service number or visit their website. More details are also available at the FDA's recall reporting site.
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