FDA Recall
Terminated
Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10.
Recall: Z-0577-03
·
Initiated December 13, 2002
Recall
- Recall Number
- Z-0577-03
- Event Number
- 25286
- Firm
- Cook Biotech, Inc.
- FEI Number
- 3002340648
- Product Code
- DXY
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 13, 2002
- Posted
- February 26, 2003
- Terminated
- May 27, 2003
- Address
- 3055 Kent Avenue, West Lafayette, IN, 47906
Description
Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10.
Reason
Adverse events- suspected pseudoaneurysm
Action
The remaining stocks were picked up at the hospital consignees on December 13 and 17, 2002.
Distribution
Indiana
Quantity
153