B Braun Medical recalled 48 IV Administration Sets on October 29, 2025, after reports of potential medication backflow. The affected sets are used with the Infusomat Space, Outlook, and Vista Basic Pumps. Healthcare providers must stop using the devices immediately and follow recall instructions.
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 IV Administration Sets are identified by catalog number 490653. Additionally, the products have Primary UDI-DI 04046955836338 and Unit of Dose UDI-DI 04046955836345. The sets were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.
The recall stems from a potential backflow of medication from secondary IV containers into primary IV containers. This issue can lead to serious medication errors and adverse patient outcomes.
While no injuries or deaths have been reported, the risk of backflow poses a high hazard to patients. Medical professionals must remain vigilant in monitoring IV administration.
Stop using the recalled IV Administration Sets immediately. Healthcare providers should contact B Braun Medical for further instructions on returning the products and receiving replacements.
To report issues or for more information, contact B Braun Medical Inc. at their customer service hotline or visit their recall notice at the FDA website.
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