Recall Z-0764-2010
Argon Medical Devices, Inc · initiated January 6, 2009
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.
Codes / lots: Lot 99715418, Exp 2014-05.
Reason for recall
One lot of Percutaneous Catheter Introducer Set contained incorrect size needle.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0764-2010
- Initiated
- January 6, 2009
- Posted by FDA
- February 2, 2010
- Terminated
- July 14, 2010
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Quantity
- 500 units
- Distribution
- Nationwide Distribution -- State of CA.
- Recalling firm
- Argon Medical Devices, Inc, Athens, TX