Recall Z-1059-2019 ยท CAC Apparatus, Autotransfusion
Fenwal Inc
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.
| Date | Feb 11, 2019 |
| Status | Terminated |
| Reason | The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use. |
| Root cause | Software design |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180831 | CATSmart Fresenius Kabi AG, Dec 10, 2018 |