Recall Z-1427-2010 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Intervascular S.A.S.
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.
| Date | Apr 23, 2010 (initiated Dec 9, 2009) |
| Status | Terminated |
| Reason | Packaging was mislabeled. |
| Root cause | 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 | 9 |
| Distribution | Nationwide Distribution - Arizona. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964625 | HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES Intervascular, Inc., May 5, 1997 |