FDA Recall
Terminated
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.
Recall: Z-1427-2010
·
Initiated December 9, 2009
Recall
- Recall Number
- Z-1427-2010
- Event Number
- 54562
- Firm
- Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France
- FEI Number
- 3002707083
- Product Code
- DSY
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- December 9, 2009
- Posted
- April 23, 2010
- Terminated
- April 27, 2010
Description
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.
Reason
Packaging was mislabeled.
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.
Distribution
Nationwide Distribution - Arizona.
Quantity
9