B Braun Medical recalled 12,320 burette sets on October 29, 2025, due to a risk of medication backflow. This defect can lead to serious health risks for patients. The recall affects devices distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.
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 product is the Burette Set with Catalog Number 490252. The device is used in gravity IV administration sets and pump administration sets for the Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The product was distributed worldwide.
The burette sets have a potential for backflow of medication from secondary IV containers into primary IV containers. This could lead to patients receiving unintended dosages of medication, posing serious health risks.
As of the recall date, no specific incidents or injuries have been reported related to this defect. However, the potential for serious health consequences necessitates immediate action.
Stop using the burette sets immediately. Follow the recall instructions provided by B Braun Medical Inc. Contact your healthcare provider for further guidance.
For more information, contact B Braun Medical Inc. or visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0621-2026.
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