Z-0764-2010

Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number...

Name: Z-0764-2010 Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number...
Creator: Argon Medical Devices, Inc
Published: 2009-01-06
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2009-01-06 / Terminated

FDA source

Argon Medical Devices, Inc began a recall of Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize... on 2009-01-06. The reason FDA records is "One lot of Percutaneous Catheter Introducer Set contained incorrect size needle". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0764-2010
Status: Terminated
Initiated: 2009-01-06
Posted: 2010-02-02
Terminated: 2010-07-14
Recalling firm: Argon Medical Devices, Inc
Product: Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA for VNUS, 5799 Fontanus Way, San Jose CA 95138 USA; General: 408-360-7200. For catheter exchange or placement of closed end catheters utilizing the Desilets-Hoffman technique.
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
Reason for recall: One lot of Percutaneous Catheter Introducer Set contained incorrect size needle.
FDA root cause: Other
Action: Firm notified sole consignee by an Urgent Medical Device Recall certified letter dated 1/6/2010. The letter identified the product being recalled and asked the consignee to immediately quarantine any product remaining at their facility. The recall should be conducted to the user level. Affected products at the consignee's facility and with their customers, should be returned using the instructions on the response form. The response forms are to completed and returned by fax or e-mail as indicated. Questions or the need for additional information concerning this recall should be directed to Sarah Larson at 903-677-9351 or [email protected].
Quantity in commerce: 500 units
Distribution: Nationwide Distribution -- State of CA.
Product codes and lots: Lot 99715418, Exp 2014-05.

Product code DRE

K780126Class IIDilator, Vessel & Introducer, SheathArgon Medical Corp. / cleared 1978-03-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)