Recall Z-1059-2019— Fenwal Inc
Class II · Terminated
Class II FDA medical device recall by Fenwal Inc, initiated 2019-02-11, terminated 2020-06-23. It names one FDA 510(k) clearance: K180831. 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: The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use..
- Recalling firm
- Fenwal Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-11
- Terminated
- 2020-06-23
- Firm location
- Lake Zurich, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.