B Braun Medical recalled 11,800 IV extension sets on October 29, 2025. The recall follows reports of potential medication backflow from secondary IV containers. Healthcare providers should stop using the device 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 recall affects IV extension sets labeled as Catalog Number 490238. The affected models include the Primary UDI-DI 04046964716409 and Unit of Dose UDI-DI 04046964716393. The product was distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.
The extension sets pose a high risk due to the potential for backflow of medication from secondary IV containers into primary IV containers. This backflow could lead to incorrect dosages and ineffective treatment.
There are no specific injury or incident counts reported at this time. However, the potential for severe health impacts exists due to medication errors.
Patients and healthcare providers must stop using the affected extension sets immediately. Follow the recall instructions provided by B Braun Medical Inc. For further guidance, contact your healthcare provider.
For more information, contact B Braun Medical Inc. Visit the FDA website for additional details on the recall.
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