B Braun Medical recalled 2,544 IV Administration Sets on October 29, 2025. The recall follows reports of 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 IV Administration Sets are labeled with Catalog Number 490451. They were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore. The sets are used in gravity and pump administration with Infusomat Space, Outlook, and Vista Basic Pumps.
The IV Administration Sets pose a high hazard risk due to the potential for backflow of medication. This backflow could lead to medication contamination or dosing errors. Users may also experience problems with priming the device, leading to occlusion.
There are no reported incidents or injuries associated with this recall at this time. However, the risk of medication backflow presents a significant safety concern.
Stop using the IV Administration Sets immediately. Follow the recall instructions provided by B Braun Medical Inc. Contact your healthcare provider for further instructions.
For more information, visit the B Braun Medical website or call the company directly. The recall notice is available at the FDA website.
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