Date Initiated by Firm | May 04, 2010 |
Date Posted | August 02, 2010 |
Recall Status1 |
Terminated 3 on February 01, 2012 |
Recall Number | Z-2126-2010 |
Recall Event ID |
55621 |
510(K)Number | K072283 |
Product Classification |
Balloon Dilatation catheter - Product Code DQY
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Product | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135512 |
Code Information |
LOT NUMBERS: 93FT0028 |
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 | 96 units |
Distribution | Nationwide |
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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