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U.S. Department of Health and Human Services

Class 2 Device Recall InterGard Knitted Collagen Coated Vascular prostheses and InterGard Woven Collagen Coated Va

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 Class 2 Device Recall InterGard Knitted Collagen Coated Vascular prostheses and InterGard Woven Collagen Coated Vasee related information
Date Initiated by FirmDecember 09, 2009
Date PostedApril 28, 2010
Recall Status1 Terminated 3 on April 29, 2010
Recall NumberZ-1439-2010
Recall Event ID 54889
510(K)NumberK964625 
Product Classification Prosthesis, vascular graft - Product Code DSY
ProductInterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
Code Information Product Reference Serial Number Lot number IGW1206 40199297 09J17 IGK2412 40200277 09J17  40200412 09J17 IGK0018-40 40200310 09J17 IGW0008-30 40199072 09J17
Recalling Firm/
Manufacturer		 Intervascular S.A.S.
Zone Industrielle Athelia I
La Ciotat Cedex France
Manufacturer Reason
for Recall		The external lid of Intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility.
FDA Determined
Cause 2		Other
ActionThe firm sent recall letters to all customers on December 9, 12009. Calls had been made prior to the letter being sent. Because all product was recovered, no additional questions are anticipated.
Quantity in Commerce5
DistributionUS Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey.
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 = DSY
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