Cardiac Assist, Inc: Medical Device Recall in 2020 - (Recall #: Z-1106-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 19, 2019

Date Posted: February 19, 2020

Recall Number: Z-1106-2020

Event ID: 84611

Reason for Recall:

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

Status: Terminated

Product Quantity: 11 kits

Code Information:

Serial Number/UDI 141445/ (01)00814112020517(17)200825(11)190423(21)00141445, 141446/ (01)00814112020517(17)200825(11)190423(21)00141446, 141447/ (01)00814112020517(17)200825(11)190423(21)00141447, 141448/ (01)00814112020517(17)200825(11)190423(21)00141448, 141449/ (01)00814112020517(17)200825(11)190423(21)00141449, 141450/ (01)00814112020517(17)200825(11)190423(21)00141450, 141451/ (01)00814112020517(17)200825(11)190429(21)00141451, 141452/ (01)00814112020517(17)200825(11)190429(21)00141452, 141453/ (01)00814112020517(17)200825(11)190429(21)00141453, 141454/ (01)00814112020517(17)200825(11)190429(21)00141454, 141457/ (01)00814112020517(17)200825(11)190429(21)00141457 Expiration Date for all products - August 25, 2020

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated