Z-0132-2008

VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138

Name: Z-0132-2008 VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138
Creator: VNUS Medical Technologies Inc
Published: 2007-03-06
License: https://open.fda.gov/license/

Vnus Medical Technologies, Inc. / initiated 2007-03-06 / Terminated / root cause: packaging

FDA source

VNUS Medical Technologies Inc began a recall of VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138 on 2007-03-06. The reason FDA records is "Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0132-2008
Status: Terminated
Initiated: 2007-03-06
Posted: 2007-12-15
Terminated: 2007-12-17
Recalling firm: Vnus Medical Technologies, Inc.
Product: VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover.
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: 269431 and 269157

Product code GEI

K061373Class IIVnus Closurefast Catheter, Models Cf7-7-60 and Cf7-7-100Vnus Medical Technologies, Inc. / cleared 2006-08-01

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)