FDA Medical Device Recalls (openFDA)
NOVADAQ TECHNOLOGIES INC.: 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 number
- Z-2767-2016
- Recalling firm
- NOVADAQ TECHNOLOGIES INC.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2016-08-18
- Posted
- not on file
- Terminated
- 2016-12-09
- 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.
- Root cause
- Packaging
- Action
- 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 quality@novadaq.com. If you have any questions, contact Director of Regulatory Affairs at 1-905-629-3822 ext 205 or email: jpendlebury@novadaq.com. .
- Quantity
- 20 units
- Distribution
- US Distribution in states of: FL, MI, and VA.
- Lot, serial or model codes
- Lot # 16047 and 16046
- 510(k) numbers
- ["K042961","K060867","K063345","K071037","K071619","K072222"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 3012345110
- Firm city
- Burnaby
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28