—#87802

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.

FDA product code: DRE — Dilator, Vessel, For Percutaneous Catheterization
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K780126
Affected lot / code info: Lot 99715418, Exp 2014-05.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751

Distribution

Distribution pattern: Nationwide Distribution -- State of CA.

Timeline

Recall initiated: 2009-01-06
Posted by FDA: 2010-02-02
Terminated: 2010-07-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87802. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.