# FDA recall Z-1059-2019

> **Fenwal Inc** · Class II · device recall initiated 2019-02-11.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1059-2019
- **Recalling firm:** Fenwal Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-11
- **Report date:** 2019-04-03
- **Termination date:** 2020-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Zurich, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1059-2019

## Citation

> AI Analytics. FDA recall Z-1059-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1059-2019. Source: US FDA. Licensed CC0.

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