Devices

Device Recall SK6000 PAQ drape pouch

Model / Serial
Lot # 16047 and 16046
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution in states of: FL, MI, and VA.
Product Description
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
NOVADAQ TECHNOLOGIES INC.
1 Event
- Recall of Device Recall SK6000 PAQ drape pouch

Manufacturer

NOVADAQ TECHNOLOGIES INC.

Manufacturer Address
NOVADAQ TECHNOLOGIES INC., 8329 Eastlake Dr Unit 101, Burnaby Canada
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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