| Class 2 Device Recall BARD E LUMINEXX BILIARY STENT | |
Date Initiated by Firm | December 23, 2008 |
Date Posted | June 17, 2009 |
Recall Status1 |
Terminated 3 on April 02, 2012 |
Recall Number | Z-1455-2009 |
Recall Event ID |
50745 |
510(K)Number | K063532 |
Product Classification |
Catheter, biliary, diagnostic - Product Code FGE
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Product | Bard E LUMINEXX, Biliary Stent Size: 6mm x 80mm, Product Number: ZBL06080. |
Code Information |
Lot Number: ANSG2333. |
Recalling Firm/ Manufacturer |
Bard Peripheral Vascular Inc 1625 W 3rd St Tempe AZ 85281-2438
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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 |
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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 = FGE
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