Recall Z-0764-2010 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
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.
| Date | Feb 2, 2010 (initiated Jan 6, 2009) |
| Status | Terminated |
| Reason | One lot of Percutaneous Catheter Introducer Set contained incorrect size needle. |
| 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 t |
| Quantity | 500 units |
| Distribution | Nationwide Distribution -- State of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780126 | DILATOR, VESSEL & INTRODUCER, SHEATH Argon Medical Corp., Mar 2, 1978 |