FDA Medical Device Recalls (openFDA)
Cook Biotech, Inc.: Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10.
- Recall number
- Z-0577-03
- Recalling firm
- Cook Biotech, Inc.
- Product
- Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10.
- Status
- Terminated
- Initiated
- 2002-12-13
- Posted
- 2003-02-26
- Terminated
- 2003-05-27
- 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
- Lot, serial or model codes
- lots SB102671, SB102908, LB203536, SB10189, SB101148, SB101402, SB102006 and SB102670.
- 510(k) numbers
- ["K001785"]
- PMA numbers
- not on file
- Product code
- DXY
- Firm FEI
- 3002340648
- Firm city
- West Lafayette
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28