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.
FDA Recall Z-1059-2019 · Posted None
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Recalling FirmFenwal Inc
Recall StatusTerminated
Product CodeCAC
Date Initiated2019-02-11
Date Terminated2020-06-23
Product Quantity198 devices
Reason for Recall
The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
Firm Action
The firm, Fresenius Kabi, sent the initial distributor a notification on about 02/11/2019 via email. Consignees were notified on about 02/18/2019 via "IMPORTANT - VACUUM UNIT for CATSmart ISSUE" letter dated 2/7/2019.
Instructions inducted that the device can still be used and there are not restrictions on the washing process. If an incident is experienced, customers are directed to contact Technical Service at 1-800-937-5060 and to provide the serial number of the device. Fresenius Kabi will be modifying the vacuum pump with a new cable mechanism to provide a secure long-term connection and updated firmware allowing for a consistent signal to the CATSmart device. The modifications will be implemented at customer locations and completed by September 1, 2019. Customers were also instructed to complete and return the Customer Reply form via fax to:1-847-550-0032.
If you have any questions, please contact the Fresenius Kabi Technical Service at 800- 937-5060. prompt 2.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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