Date Initiated by Firm | March 26, 2009 |
Date Posted | August 26, 2009 |
Recall Status1 |
Terminated 3 on April 02, 2012 |
Recall Number | Z-1881-2009 |
Recall Event ID |
52455 |
510(K)Number | K082681 |
Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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Product | MR Coaxial 10g x 140mm (VC10140MR). |
Code Information |
Lot Numbers: HUSC1247, HUSC 1566, HUSE0137, HUSE0138, HUSG0599 and HUSH1234. |
Recalling Firm/ Manufacturer |
Bard Peripheral Vas 1415 W 3rd St Ste 109 Tempe AZ 85281-7634
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Manufacturer Reason for Recall | Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure. |
FDA Determined Cause 2 | Process control |
Action | Bard Peripheral Vascular, Inc. issued an "Urgent Medical Device Recall Notification" dated March 27, 2009 informing Customers of the affected devices. The firm requested that all affected product be removed and returned along with returning a Recall and Effectiveness Check Form via fax.
For further information, contact Bard Peripheral Vascular, Inc. at 1-800-321-4254. |
Quantity in Commerce | 695 |
Distribution | Worldwide Distribution. |
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 = DWF
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