Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10.
FDA device recall Z-0577-03 · posted 2003-02-26 · Terminated
Recall details
- Recalling firm
- Cook Biotech, Inc.
- Reason for recall
- Adverse events- suspected pseudoaneurysm
- Action taken
- The remaining stocks were picked up at the hospital consignees on December 13 and 17, 2002.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXY
- Quantity affected
- 153
- Distribution
- Indiana
- Date initiated
- 2002-12-13
- Date posted
- 2003-02-26
- Date terminated
- 2003-05-27
- Location
- West Lafayette, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGISIS PERIPHERAL VASCULAR PATCH (K001785) | Cook Biotech, Inc. | 2000-12-27 |