Recall Z-1413-2015 ยท DQY Catheter, Percutaneous
Bard Peripheral Vascular Inc
Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
| Date | Apr 10, 2015 (initiated Mar 23, 2015) |
| Status | Terminated |
| Reason | Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues. |
| Root cause | Process control |
| Action | Bard sent an Urgent Medical Device Recall Notification letter dated March 23, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informs the customers that the product code and lot combination listed on the attachment 1 of the recall letter may be at risk of having deflation related issues. Customers are instructed to complete and return the Effectiveness Check Form. Customers with questions are instructed to call Bard Peripheral Vascular's (BPV) at (800) 321-4254 option #2 Ext 2501 (M-F 7am-4pm |
| Quantity | 2620 units |
| Distribution | Worldwide Distribution - US Distribution including Puerto Rico and the countries of : Austria, Belgium, Germany, France, Greece, Iran, Ireland, Israel, Martinique, Netherlands, Portugal, Russia, Slovenia, South Africa, Spain, United Arab Emirates (UAE), United Kingdom, Canada, Korea, Taiwan, Singap |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083657 | CONQUEST PTA BALLOON DILATATION CATHETER C.R. Bard, Inc., Dec 24, 2008 |