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U.S. Department of Health and Human Services

Class 2 Device Recall SK6000 PAQ drape pouch

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 Class 2 Device Recall SK6000 PAQ drape pouchsee related information
Date Initiated by FirmAugust 18, 2016
Create DateSeptember 08, 2016
Recall Status1 Terminated 3 on December 09, 2016
Recall NumberZ-2767-2016
Recall Event ID 75006
510(K)NumberK042961 K060867 K063345 K071037 K071619 K072222 
Product Classification System, x-ray, angiographic - Product Code IZI
ProductSterile 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.
Code Information Lot # 16047 and 16046
Recalling Firm/
Manufacturer		 NOVADAQ TECHNOLOGIES INC.
8329 Eastlake Dr Unit 101
Burnaby Canada
Manufacturer 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.
FDA Determined
Cause 2		Packaging
ActionThe 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 in Commerce20 units
DistributionUS Distribution in states of: FL, MI, and VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IZI
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