B Braun Medical recalled over 20 million IV administration sets on October 29, 2025. The recall stems from a potential backflow of medication that could put patients at risk. Healthcare providers and patients must 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 recall affects 20,694,734 IV administration sets including various catalog numbers such as 352636, 352639, and 490562. These products were distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.
The recalled IV administration sets pose a risk of backflow of medication from secondary IV containers into primary IV containers. This could lead to incorrect dosages and serious health complications.
Currently, there are no reported injuries or incidents linked to the recalled IV administration sets. The potential risks associated with backflow could lead to severe patient harm.
Stop using the recalled IV administration sets immediately. Follow the recall instructions from B Braun Medical and contact your healthcare provider for further guidance.
For more information, call B Braun Medical at [insert phone number] or visit their website at [insert website]. Additional resources can be found at the FDA recall page.
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