Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800
FDA device recall Z-0268-06 · posted 2005-12-03 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc., Urological Division
- Reason for recall
- There is a potential for the lumen to collapse and prevent passage over a guidewire.
- Action taken
- Consignees were notified via overnight courier on 11/7&8/2005
- Root cause
- Other
- Status
- Terminated
- Product code
- EZN
- Quantity affected
- 480 units
- Distribution
- Nationwide, Belgium, Canada
- Date initiated
- 2005-11-03
- Date posted
- 2005-12-03
- Date terminated
- 2006-01-24
- Location
- Covington, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARD UROFORCE BALLOON DILATION CATHETER (K993840) | C.R. Bard, Inc. | 2000-01-31 |