Recovery G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism.
FDA device recall Z-0394-2007 · posted 2007-02-01 · Terminated
Recall details
- Recalling firm
- Bard Peripheral Vascular Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTK
- Quantity affected
- 124 units
- Distribution
- Worldwide including USA, Australia, and Canada
- Date initiated
- 2006-12-20
- Date posted
- 2007-02-01
- Date terminated
- 2008-10-23
- Location
- Tempe, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J (K052578) | Bard Peripheral Vascular, Inc. | 2005-11-25 |