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NOVADAQ TECHNOLOGIES INC. recalls Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent I
Recalled September 14, 2016 · FDA recall Z-2767-2016 · NOVADAQ TECHNOLOGIES
Hazard
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. · FDA Class II
Units
20 units
Sold at
US Distribution in states of: FL, MI, and VA.
Description
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.
Product
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.
Manufacturer(s)
NOVADAQ TECHNOLOGIES INC.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →