NOVADAQ TECHNOLOGIES INC. recalls Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Ima…

Recall date

August 18, 2016

Source

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

Recall number

Z-2767-2016

FDA classification

Class II

Brand / firm

NOVADAQ TECHNOLOGIES INC.

Sold / distributed

US Distribution in states of: FL, MI, and VA.

Why it was recalled

Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing.

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

What was recalled

Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.