FDA-Device2019-04-03Class II
Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
Fenwal Inc
Hazard
The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
Sold states
US Nationwide Distribution to states of: AZ, CA, FL, HI, ID, IL, IN, MD, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OK, OR, PA, TN, TX, VA and PR; and Internationally to Canada.
Affected count
198 devices
Manufactured in
3 Corporate Dr Ste 300, N/A, Lake Zurich, IL, United States
Products
Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1059-2019Don't want to check this manually?
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