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U.S. Department of Health and Human Services

Class 2 Device Recall ConQuest PTA Dilation Catheter

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  Class 2 Device Recall ConQuest PTA Dilation Catheter see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = C.R. BARD, INC.
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