Z-2767-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2016
- Initiation Date
- August 18, 2016
- Termination Date
- December 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
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.
Reason for Recall
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.
Distribution Pattern
US Distribution in states of: FL, MI, and VA.
Code Information
Lot # 16047 and 16046