# FDA recall Z-1106-2020

> **Cardiac Assist, Inc** · Class II · device recall initiated 2019-11-19.

## Product

TandemLife ECLS Procedure Kit - V24/A17, Catalog Number  5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

## Reason for recall

The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.

## Distribution

US Nationwide distribution in the states of AZ, AL, ME, LA, PA.

## Key facts

- **Recall number:** Z-1106-2020
- **Recalling firm:** Cardiac Assist, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-19
- **Report date:** 2020-02-19
- **Termination date:** 2020-10-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pittsburgh, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1106-2020

## Citation

> AI Analytics. FDA recall Z-1106-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1106-2020. Source: US FDA. Licensed CC0.

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