FDA-Device2023-11-01Class I
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
B. Braun Medical, Inc.
Hazard
Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.
Sold states
Domestic distribution nationwide. Foreign distribution to Canada.
Affected count
9771
Manufactured in
901 Marcon Blvd, N/A, Allentown, PA, United States
Products
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0123-2024Don't want to check this manually?
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