FDA Enforcement
Class II
Terminated
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: Z-2767-2016
·
Reported September 14, 2016
Enforcement
- Recall Number
- Z-2767-2016
- Event ID
- 75006
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- NOVADAQ TECHNOLOGIES INC.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 14, 2016
- Initiation Date
- August 18, 2016
- Classification Date
- September 8, 2016
- Termination Date
- December 9, 2016
- Address
- 8329 Eastlake Dr Unit 101, Burnaby, N/A, 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.
Reason
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.
Code Info
Lot # 16047 and 16046
Distribution
US Distribution in states of: FL, MI, and VA.
Quantity
20 units