B Braun Medical recalled 36,936 IV Administration Sets on October 29, 2025. The recall stems from a potential backflow of medication from secondary IV containers into primary IV containers. Healthcare providers and patients should stop using the 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 the IV Administration Set with 15 drops/mL, catalog number 490504. This set was used in conjunction with B Braun Medical's Infusomat Space, Outlook, and Vista Basic Pumps. The product was distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.
The IV Administration Sets may allow medication to backflow from secondary IV containers into primary IV containers. This could lead to dosing errors and potential harm to patients. The recall is classified as Class II due to the high hazard level.
There are no specific incidents of injury reported at this time. The FDA classified the issue as a high hazard due to potential risks associated with medication backflow.
Stop using the recalled IV Administration Sets immediately. Follow the instructions provided by the manufacturer for a safe return or disposal. Contact B Braun Medical Inc or your healthcare provider for further instructions.
Consumers can reach B Braun Medical Inc for more information. Visit their website or call the provided contact number for assistance.
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