Fenwal Inc recalls Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the pro

Recalled April 3, 2019 · FDA recall Z-1059-2019 · Fenwal

Hazard

The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use. · FDA Class II

Units

198 devices

Sold at

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.

Description

The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.

Product

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.

Manufacturer(s)

Fenwal Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →