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

Product Reference Serial Number Lot number IGW1206 40199297 09J17 IGK2412 40200277 09J17  40200412 09J17 IGK0018-40 40200310 09J17 IGW0008-30 40199072 09J17

Cardiovascular Devices

2

Yes

US Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey.

InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; || InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.