B Braun Medical recalled 381,850 IV administration sets on October 29, 2025. The recall addresses potential backflow of medication from secondary IV containers into primary containers. This issue poses a significant risk to patients and healthcare providers worldwide.
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 products include the Primary Gravity Filtered Set with 2 CARESITE Injection Sites, Catalog Number: 354207, and additional units with UDI-DI numbers 04046964182136 and 04046964182129. The sets were distributed internationally, including the US, Canada, Germany, Guatemala, and Singapore.
The IV administration sets may allow backflow of medication from secondary IV containers into primary containers. This can lead to serious complications for patients receiving treatment. The recall is classified as Class II, indicating a moderate risk.
There have been no reported injuries or deaths associated with this recall. However, the potential for medication backflow could lead to serious health risks.
Stop using the recalled IV administration sets immediately. Follow the manufacturer's recall instructions and contact B Braun Medical Inc or your healthcare provider for further instructions.
For more information, call B Braun Medical Inc. at 1-800-227-2862 or visit their website. Additional details are available at the FDA's recall page.
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