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.
Recall
- Recall Number
- Z-2767-2016
- Event Number
- 75006
- Firm
- NOVADAQ TECHNOLOGIES INC.
- FEI Number
- 3012345110
- Product Code
- IZI
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- August 18, 2016
- Terminated
- December 9, 2016
- Address
- 8329 Eastlake Dr, Unit 101, Burnaby Canada
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.
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.
The firm, Novadaq, sent an "URGENT DEVICE CORRECTION: SK6000 PAQ Drape Pouch" letter dated 8/18/2016 to affected consignees. The Firm instructed consignee to cease distribution of affected product; accept the shipping-validated replacement PAQ; complete and sign the enclosed "Acknowledgment of Receipt" form, scan it and email to [email protected]. If you have any questions, contact Director of Regulatory Affairs at 1-905-629-3822 ext 205 or email: [email protected]. .
US Distribution in states of: FL, MI, and VA.
20 units