Recall Z-0268-06 ยท EZN Dilator, Catheter, Ureteral
C.R. Bard, Inc., Urological Division
Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO
| Date | Dec 3, 2005 (initiated Nov 3, 2005) |
| Status | Terminated |
| Reason | There is a potential for the lumen to collapse and prevent passage over a guidewire. |
| Root cause | Other |
| Action | Consignees were notified via overnight courier on 11/7&8/2005 |
| Quantity | 480 units |
| Distribution | Nationwide, Belgium, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993840 | BARD UROFORCE BALLOON DILATION CATHETER C.R. Bard, Inc., Jan 31, 2000 |