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U.S. Department of Health and Human Services

Class 3 Device Recall LUNA Paq, Model No. LU3006

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 Class 3 Device Recall LUNA Paq, Model No. LU3006see related information
Date Initiated by FirmNovember 04, 2014
Date PostedDecember 01, 2014
Recall Status1 Terminated 3 on November 06, 2015
Recall NumberZ-0470-2015
Recall Event ID 69839
510(K)NumberK071619 
Product Classification System, x-ray, angiographic - Product Code IZI
ProductNon-sterile drape
Code Information Kit Lot Numbers: 14082, 14091, 14104, 14106 Drape Lot Numbers: D132712, D133102, D141022, D130282 
Recalling Firm/
Manufacturer		 Novadaq Technologies, Inc.
13155 Delf Place
Richmond Canada British Columbia
Manufacturer Reason
for Recall		Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
FDA Determined
Cause 2		Error in labeling
ActionNovadaq initiated their recall by telephone and followed by an email and a Medical Device Recall Notice dated November 11, 2014, to all affected customers. Distributors were instructed to notify their customers. The firm is removing the recalled products and replacing them with correctly labeled product. Customers were instructed to confirm receipt of the Recall Notice and their understanding of the actions to be taken by completing the attached confirmation form and faxing it to Novadaq Quality Department at 1-800-886-2419. For questions regarding this recall call 604-432-9861.
Quantity in Commerce324 units
DistributionNationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.
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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