Argon Medical Devices, Inc 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

One lot of Percutaneous Catheter Introducer Set contained incorrect size needle.

Recommended Action

Per FDA guidance

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 Sarah.Larson@argonmedical.com.