B Braun Medical recalled 300 IV administration sets on October 29, 2025, due to a risk of medication backflow. The defect affects the ability to prime IV containers. Healthcare providers should stop using these 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 labeled as EXT/2INJ/FLBL/FML LRLK/CV 34, Catalog Number: V5405. It has a Primary UDI-DI of 04046964188978 and a Unit of Dose UDI-DI of 04046964188961. The product was distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.
The recall addresses a potential backflow of medication from secondary IV containers into primary IV containers. This defect may lead to serious complications in patient care due to medication contamination.
There have been no specific reported injuries or fatalities linked to this recall. However, the potential for medication backflow presents a high-risk situation for patients.
Patients and healthcare providers should stop using the IV administration sets immediately. Follow the recall instructions provided by B Braun Medical. Contact B Braun Medical Inc or your healthcare provider for further instructions.
For more information, contact B Braun Medical Inc. at their customer service number or visit their website.
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