Events

Recall of Device Recall SK6000 PAQ drape pouch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by NOVADAQ TECHNOLOGIES INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75006
  • Event Risk Class
    Class 2
  • Event Number
    Z-2767-2016
  • Event Initiated Date
    2016-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149092
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, angiographic - Product Code IZI
  • 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.
  • 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. .

Device

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.

Manufacturer

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