Recall Z-0393-2007 ยท DTK Filter, Intravascular, Cardiovascular
Bard Peripheral Vascular Inc
G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-320J
| Date | Feb 1, 2007 (initiated Dec 20, 2006) |
| Status | Terminated |
| Reason | This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity. |
| Root cause | Other |
| Action | Recall letters were sent to all consignees via Federal Express overnight delivery with signature receipt required on December 20, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Bard Peripheral Vascular, Inc (BPV). Customers will be asked to immediately remove product from inventory and isolated from use and contact BARD for return authorization. All returned product will be destroyed. |
| Quantity | 5761 units |
| Distribution | Worldwide including USA, Australia, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052578 | BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J Bard Peripheral Vascular, Inc., Nov 25, 2005 |