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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 Recall
Vacora Plastic Radiolucent Coaxial
see related information
Date Posted August 26, 2009
Recall Status1 Open
Recall Number Z-1882-2009
Recall Event ID 52455
Premarket Notification
510(K) Number
K082681 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product MR Coaxial 10g x 118mm (VC10118MR).
Code Information Lot Numbers: HUSC1250, HUSC1587, HUSC1588, HUSC1589, HUSD2646, HUSD2647, HUSD2648, HUSF1690, HUSH0816, HUSI0216 and HUSK1723.
Recalling Firm/
Manufacturer
Bard Peripheral Vas
1415 W 3rd St Ste 109
Tempe, Arizona 85281-7634
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 1,440
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = C.R. BARD, INC.
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