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U.S. Department of Health and Human Services

Class 2 Device Recall BARD E LUMINEXX BILIARY STENT

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  Class 2 Device Recall BARD E LUMINEXX BILIARY STENT see related information
Date Initiated by Firm December 23, 2008
Date Posted June 17, 2009
Recall Status1 Terminated 3 on April 02, 2012
Recall Number Z-1465-2009
Recall Event ID 50745
510(K)Number K063532  
Product Classification Catheter, biliary, diagnostic - Product Code FGE
Product Bard E LUMINEXX Biliary Stent, Size: 12mm x 80mm Product Number: ZBM12080.
Code Information Lot Numbers: ANSH0792 and ANSI0311.
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		 This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use".
FDA Determined
Cause 2		 Employee error
Action Bard Peripheral Vascular, Inc. (BVP) sent an "Urgent - Product Recall Notice" letter to consignees dated December 22, 2008 outlining the reason for the recall. In the letter, customers were informed to check all inventory locations, stop any further distribution of and return affected product to BPV. Consignees were to complete the enclosed Recall and Effectiveness Check Form and fax to 1-800-440-5376 or send information by phone at 1-800-321-4254 extension 2727 or e-mail at silvia.carillo@crbard.com.
Quantity in Commerce 94 units total for all product codes
Distribution Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.
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 = FGE and Original Applicant = BARD PERIPHERAL VASCULAR, INC.
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