Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sterile Drape Recalled by NOVADAQ TECHNOLOGIES INC. Due to Novadaq is informing SK6000 PAQ users that a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact NOVADAQ TECHNOLOGIES INC. directly.
Affected Products
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.
Quantity: 20 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 3 states: FL, MI, VA
About NOVADAQ TECHNOLOGIES INC.
NOVADAQ TECHNOLOGIES INC. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report