| Class 2 Device Recall ConQuest PTA Dilation Catheter |  |
Date Initiated by Firm | March 23, 2015 |
Date Posted | April 10, 2015 |
Recall Status1 |
Terminated 3 on August 28, 2015 |
Recall Number | Z-1413-2015 |
Recall Event ID |
70839 |
510(K)Number | K083657 |
Product Classification |
Catheter, percutaneous - Product Code DQY
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Product | Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124. |
Code Information |
Lot No. REYA0973, REYA2566, REYC0372, REYC0950, REYC1426, REYC2200, REYC2365, REYC2825, REYC2575 |
Recalling Firm/ Manufacturer |
Bard Peripheral Vascular Inc 1625 W 3rd St Ste 109 Tempe AZ 85281-2438
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For Additional Information Contact | Raye Seisinger 800-321-4254 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 MST) Customers are instructed to fax the recall and effectiveness check form to BPV at (800) 994-6772. |
Quantity in Commerce | 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, Singapore, Thailand, Chile, Guam, Mexico, Malaysia and Australia. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DQY
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