Cardiac Assist, Inc recalls TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo…

Recall date

November 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1106-2020

FDA classification

Class II

Brand / firm

Cardiac Assist, Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.