Recall Z-0577-03 ยท DXY Implantable Pacemaker Pulse-Generator
Cook Biotech, Inc.
Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10.
| Date | Feb 26, 2003 (initiated Dec 13, 2002) |
| Status | Terminated |
| Reason | Adverse events- suspected pseudoaneurysm |
| Root cause | Other |
| Action | The remaining stocks were picked up at the hospital consignees on December 13 and 17, 2002. |
| Quantity | 153 |
| Distribution | Indiana |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001785 | SURGISIS PERIPHERAL VASCULAR PATCH Cook Biotech, Inc., Dec 27, 2000 |