Vacuum Unit for CATSmart Vacuum Pump — Class II medical device recall Z-1059-2019
Terminated recall by Fenwal Inc, reported 2019-04-03, distributed nationwide. The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
| Recall number | Z-1059-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fenwal Inc, Lake Zurich, IL, United States |
| Recall initiated | 2019-02-11 |
| Classified | 2019-03-26 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-06-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 198 devices |
| Serial numbers | 5VTA0180, 5VTA0183, 5VTA0194, 5VTA0195, 5VTA0196, 5VTA0197, 5VTA0198, 5VTA0199, 5VTA0200, 5VTA0201, 5VTA0202, 5VTA0203, 5VTA0204, 5VTA0205, 5VTA0206, 5VTA0234, 5VTA0235, 5VTA0236, 5VTA0237, 5VTA0238, 5VTA0239, 5VTA0240, 5VTA0241, 5VTA0242, 5VTA0243 and 311 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1059-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.