Bard E LUMINEXX Biliary Stent, Size: 6mm x 80mm, Product Number: ZBM06080.
FDA Recall Z-1462-2009 · Posted 2009-06-17
Recalling FirmBard Peripheral Vascular Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2008-12-23
Date Terminated2012-04-02
Product Quantity94 units total for all product codes
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".
Firm 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 [email protected].
Root Cause
Employee error
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.