B Braun Medical recalled IV Administration Sets on October 29, 2025, due to a backflow risk. The recall affects devices used with Infusomat Space, Outlook, and Vista Basic Pumps. Healthcare providers should stop using the product 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 includes IV Administration Set, 110 IN. with Catalog Number 490566. The devices were distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.
The recalled IV Administration Sets may allow medication to backflow from secondary IV containers into primary containers. This could lead to potential medication errors and adverse health effects.
No specific injuries or incidents have been reported at this time. The recall was initiated due to the identified risk.
Stop using the recalled IV Administration Sets immediately. Follow the recall instructions provided by the manufacturer and contact B Braun Medical or your healthcare provider for further guidance.
For more information, contact B Braun Medical Inc. Visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0718-2026.
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