FDA recall Z-1106-2020

Cardiac Assist, Inc · Class II · device

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

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

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