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U.S. Department of Health and Human Services

Class 2 Device Recall InterGard Knitted Collagen Coated Vascular prostheses

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  Class 2 Device Recall InterGard Knitted Collagen Coated Vascular prostheses see related information
Date Initiated by Firm December 09, 2009
Date Posted April 23, 2010
Recall Status1 Terminated 3 on April 27, 2010
Recall Number Z-1427-2010
Recall Event ID 54562
510(K)Number K964625  
Product Classification Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
Product InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France.

Indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.
Code Information Serial Number: 40246657, Lot number: 09M03.
Recalling Firm/
Manufacturer		 Intervascular S.A.S.
Zone Industrielle Athelia I
La Ciotat Cedex France
Manufacturer Reason
for Recall		 Packaging was mislabeled.
FDA Determined
Cause 2		 Labeling mix-ups
Action InterVascular SAS issued a "Recall Notification - Product Recall RC 020" notification dated January 29, 2009 to the sole consignee. The consignee had previously been notified by phone and all affected product had been segregated. For further information, contact InterVascular SAS at +33 442 08 77 84.
Quantity in Commerce 9
Distribution Nationwide Distribution - Arizona.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DSY and Original Applicant = INTERVASCULAR, INC.
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