B Braun Medical recalled 9,500 IV administration sets on October 29, 2025, due to a risk of medication backflow. The recall affects models used in conjunction with the Infusomat Space, Outlook, and Vista Basic pumps. Healthcare providers and patients must stop using these devices immediately to avoid serious health risks.
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 490070 and primary UDI-DI 04046964301582. These products have worldwide distribution, including the US, Canada, Germany, Guatemala, and Singapore. The sets were sold for an undisclosed price.
The recalled IV administration sets pose a high risk of backflow of medication from secondary IV containers into primary containers. This backflow can lead to medication errors and potential harm to patients.
As of the latest report, there are no specific incidents or injuries documented related to this recall. However, the potential for serious health risks warrants immediate action.
Patients and healthcare providers must stop using the recalled IV administration sets immediately. Follow the recall instructions provided by B Braun Medical Inc. For further guidance, contact your healthcare provider.
For more information about the recall, visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0701-2026.
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