Reported Apr 3, 2019 · Terminated
Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the…
Fenwal Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fenwal Inc · 3 Corporate Dr Ste 300 · Lake Zurich, IL · 60047-8930
Is this the product you have?
- 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.
- Lot codes and dates
- Material Number 9005851
- Serial Numbers
336 of 336 codes
5VTA01805VTA01835VTA01945VTA01955VTA01965VTA01975VTA01985VTA01995VTA02005VTA02015VTA02025VTA02035VTA02045VTA02055VTA02065VTA02345VTA02355VTA02365VTA02375VTA02385VTA02395VTA02405VTA02415VTA02425VTA02435VTA02445VTA02455VTA02465VTA02475VTA02485VTA02495VTA02505VTA02515VTA02525VTA02535VTA02545VTA02555VTA02566VTA02576VTA02586VTA02596VTA02606VTA02616VTA02626VTA02636VTA02646VTA02656VTA02666VTA02896VTA02956VTA02966VTA02976VTA02986VTA02996VTA03006VTA03016VTA03026VTA03036VTA03046VTA0305
- Amount recalled
- 198 devices
Where it was sold
Why it was recalled
The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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