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U.S. Department of Health and Human Services

Class 2 Device Recall BARD DORADO

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  Class 2 Device Recall BARD DORADO see related information
Date Initiated by Firm May 04, 2010
Date Posted August 02, 2010
Recall Status1 Terminated 3 on February 01, 2012
Recall Number Z-2136-2010
Recall Event ID 55621
510(K)Number K072283  
Product Classification Balloon Dilatation catheter - Product Code DQY
Product BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135720
Code Information LOT NUMBERS: 93FT0218, 93HT0155
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St
Tempe AZ 85281-2438
For Additional Information Contact
480-894-9515
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 products. Additionally they were asked to fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772.
Quantity in Commerce 135 units
Distribution Nationwide
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 = BARD PERIPHERAL VASCULAR, INC.
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