Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion Recalled by Fenwal Inc Due to The optional Vacuum Unit may stop working and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fenwal Inc directly.
Affected Products
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.
Quantity: 198 devices
Why Was This Recalled?
The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fenwal Inc
Fenwal Inc has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report