FDA recall Z-1059-2019

Fenwal Inc · Class II · device

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.

Reason for recall

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

Distribution

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.

Key facts

Status
Terminated
Initiation date
2019-02-11
Report date
2019-04-03
Termination date
2020-06-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1059-2019