—#76920

Product

Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBM06040.

FDA product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K063532
Affected lot / code info: Lot Numbers: ANSH0294 and ANSI0239.

Why it was recalled

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".

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Tempe, Arizona 85281-2438

Distribution

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.

Timeline

Recall initiated: 2008-12-23
Posted by FDA: 2009-06-17
Terminated: 2012-04-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #76920. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.