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.
Reported: April 3, 2019 Initiated: February 11, 2019 #Z-1059-2019
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.
Details
- Recalling Firm
- Fenwal Inc
- Units Affected
- 198 devices
- 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.
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product 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.. Recalled by Fenwal Inc. Units affected: 198 devices.
Why was this product recalled? ▼
The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2019. Severity: Moderate. Recall number: Z-1059-2019.
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