Recall Z-0638-04 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Datascope Corporation
HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; HEK25/100CPUT; HEK12/75CPUT; HEK10/150CPUT.
| Date | Jul 20, 2004 (initiated Dec 30, 2003) |
| Status | Terminated |
| Reason | Water permeability of the patch is out of specification. |
| Root cause | Other |
| Action | Recall letters were sent to the customers via US Mail return receipt on 12/30/2003. |
| Quantity | 710 units |
| Distribution | The product has been shipped nationwide to 53 hospitals, 4 government hospitals, and 3 sales representatives. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983819 | INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN Intervascular, Inc., Nov 24, 1998 |