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

Recall date

February 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1059-2019

FDA classification

Class II

Brand / firm

Fenwal Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.