Recall Z-2127-2010 ยท DQY Catheter, Percutaneous
Bard Peripheral Vascular Inc
BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135515
| Date | Aug 2, 2010 (initiated May 4, 2010) |
| Status | Terminated |
| Reason | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| Root cause | Nonconforming Material/Component |
| Action | The Bard Peripheral Vascular "URGENT MEDICAL DEVICE RECALL NOTIFICATION" with attached "RECALL AND EFFECTIVENESS CHECK FORM" was sent to the affected consignees beginning May 7, 2010 via FedEx. The recall notice informed the consignees of the reason for recall, the products affected and instructed them not to use or further distribute any affected product. The consignees were also instructed to call the firm's Recall Coordinator Silvia Carrillo at 1-800-321-4254 Option #2 Ext 2727 (M-F 7am to 4pm MST) or email at silvia.carrillo@crbard.com to facilitate the expedient return of the affected |
| Quantity | 406 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072283 | DORADO PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc., Sep 19, 2007 |