Recall Z-1439-2010 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Intervascular S.A.S.
InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
| Date | Apr 28, 2010 (initiated Dec 9, 2009) |
| Status | Terminated |
| Reason | The external lid of Intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility. |
| Root cause | Other |
| Action | The 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 | 5 |
| Distribution | US Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey. |
| 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 |