FDA Medical Device Recalls (openFDA)
Vascular Solutions, Inc: Vari-Lase Endovenous Laser Procedural Kit, Model 7000
- Recall number
- Z-0101-04
- Recalling firm
- Vascular Solutions, Inc
- Product
- Vari-Lase Endovenous Laser Procedural Kit, Model 7000
- Status
- Terminated
- Initiated
- 2003-10-09
- Posted
- 2003-11-06
- Terminated
- 2005-11-21
- Reason
- An internal gasket of the Fiber Lock component of the Vari-Lase Kit contains natural rubber latex, but the product labeling does not recognize the presence of latex and include the required cautionary statement.
- Root cause
- Other
- Action
- Letters dated October 9, 2003 were sent to the consignees. The letters instruct the consignees to place the enclosed warning stickers, about latex in the product, on the boxes and pouches of any remaining product in inventory at the consignees. After completing the relabeling, consignees are to fill out the attached form and fax it to the firm to document the field correction.
- Quantity
- 390 kits
- Distribution
- The product was distributed nationwide in the United States and to Romania.
- Lot, serial or model codes
- Lot numbers S000102, 300537, and 300536.
- 510(k) numbers
- ["K030654"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3002827704
- Firm city
- Minneapolis
- Firm state
- MN
- 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