FDA Medical Device Recalls (openFDA)
VNUS Medical Technologies Inc: VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138
- Recall number
- Z-0132-2008
- Recalling firm
- VNUS Medical Technologies Inc
- Product
- VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138
- Status
- Terminated
- Initiated
- 2007-03-06
- Posted
- 2007-12-15
- Terminated
- 2007-12-17
- Reason
- Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover.
- Root cause
- Package design/selection
- Action
- The recalling firm has issued customer notification letters by mail on 03/06/2007. The firm is requesting that consignees discontinue their use of the device and return recalled product . The firm will provide replacements.
- Quantity
- 92 units
- Distribution
- Nationwide: Product was distributed to 18 health care providers and medical centers throughout the US in the following states: TX, UT, CA, CT, MI, NY, MI, OR, WA, VA, PA, and NJ.
- Lot, serial or model codes
- Lot Numbers: 269431 and 269157
- 510(k) numbers
- ["K061373"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3001236355
- Firm city
- San Jose
- Firm state
- CA
- 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