B Braun Medical recalled 286,400 IV administration sets on October 29, 2025. The recall follows reports of potential backflow of medication from secondary IV containers into primary IV containers. Users must stop using the devices immediately and follow the manufacturer's 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 product is the IV Administration Set, catalog number 354211. It was distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore. The sets were sold for an undisclosed price.
The IV administration set poses a high hazard risk due to the potential for backflow of medication from secondary IV containers into primary IV containers. This backflow can lead to incorrect dosing or contamination.
No specific incidents of injury or death have been reported. The recall is classified as Class II, indicating a risk of serious injury.
Stop using the IV administration set immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions and to follow the recall process.
For more information, call B Braun Medical Inc at 1-800-xxx-xxxx or visit their website at www.bbraun.com.
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