B Braun Medical recalled 126,050 IV administration sets on October 29, 2025. The recall affects devices used with the Infusomat Space, Outlook, and Vista pumps. Users face a high risk of medication backflow and occlusions.
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 include Catalog Number 354208. These devices were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.
The IV administration sets may allow backflow of medication from secondary IV containers into primary IV containers. This malfunction can lead to improper dosing and potential adverse health effects.
No specific incidents or injuries have been reported to date, but the risk remains significant due to the nature of the malfunction.
Stop using the recalled IV administration sets immediately. Follow the manufacturer's recall instructions and contact B Braun Medical Inc or your healthcare provider for further information.
For more information, visit B Braun Medical's website or call their customer service line. Further details are available at the FDA's recall page.
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