MR Coaxial 10g x 140mm (VC10140MR).
FDA device recall Z-1881-2009 · posted 2009-08-26 · Terminated
Recall details
- Recalling firm
- Bard Peripheral Vas
- Reason for recall
- Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure.
- Action taken
- Bard Peripheral Vascular, Inc. issued an "Urgent Medical Device Recall Notification" dated March 27, 2009 informing Customers of the affected devices. The firm requested that all affected product be removed and returned along with returning a Recall and Effectiveness Check Form via fax. For further information, contact Bard Peripheral Vascular, Inc. at 1-800-321-4254.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 695
- Distribution
- Worldwide Distribution.
- Date initiated
- 2009-03-26
- Date posted
- 2009-08-26
- Date terminated
- 2012-04-02
- 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 |
|---|---|---|
| VACORA VACUUM ASSISTED BIOPSY SYSTEM (K082681) | C.R. Bard, Inc. | 2008-10-15 |