Z-0101-04

Vari-Lase Endovenous Laser Procedural Kit, Model 7000

Name: Z-0101-04 Vari-Lase Endovenous Laser Procedural Kit, Model 7000
Creator: Vascular Solutions, Inc
Published: 2003-10-09
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2003-10-09 / Terminated / root cause: labeling and UDI

FDA source

Vascular Solutions, Inc began a recall of Vari-Lase Endovenous Laser Procedural Kit, Model 7000 on 2003-10-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0101-04
Status: Terminated
Initiated: 2003-10-09
Posted: 2003-11-06
Terminated: 2005-11-21
Recalling firm: Vascular Solutions LLC
Product: Vari-Lase Endovenous Laser Procedural Kit, Model 7000
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 390 kits
Distribution: The product was distributed nationwide in the United States and to Romania.
Product codes and lots: Lot numbers S000102, 300537, and 300536.

Product code GEX

K030654Class IIVascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. / cleared 2003-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)