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FDAAugust 18, 2016device

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. F...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

novadaq technologiesnovadaq

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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