B Braun Medical recalled 31,392 IV administration sets on October 29, 2025, due to a high risk of medication backflow. The affected models include catalog number 490301. This recall affects devices distributed worldwide, including the US and Canada.
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 with catalog number 490301. It was distributed globally, including markets in Canada, Germany, Guatemala, and Singapore. The product has a shelf life of 36 months.
The recall addresses a significant risk of medication backflow from secondary IV containers into primary containers. This issue can result in incorrect dosing and potential harm to patients.
There have been no reported incidents or injuries related to this recall. However, the potential for serious harm exists due to the nature of the malfunction.
Healthcare providers and patients should stop using the IV administration set immediately. Follow the recall instructions provided by B Braun Medical Inc for further guidance.
For more information, contact B Braun Medical Inc. Visit the FDA website for official recall details at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0703-2026.
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