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U.S. Department of Health and Human Services

Class 2 Device Recall Vacora Plastic Radiolucent Coaxial

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  Class 2 Device Recall Vacora Plastic Radiolucent Coaxial see related information
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
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
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
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 = DWF and Original Applicant = C.R. BARD, INC.
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