Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
FDA device recall Z-1413-2015 · posted 2015-04-10 · Terminated
Recall details
- Recalling firm
- Bard Peripheral Vascular Inc
- Reason for recall
- Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues.
- Action taken
- 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 MST) Customers are instructed to fax the recall and effectiveness check form to BPV at (800) 994-6772.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 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, Slove
- Date initiated
- 2015-03-23
- Date posted
- 2015-04-10
- Date terminated
- 2015-08-28
- Location
- Tempe, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONQUEST PTA BALLOON DILATATION CATHETER (K083657) | C.R. Bard, Inc. | 2008-12-24 |