Z-1454-2009

Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBL06040

Name: Z-1454-2009 Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBL06040
Creator: Bard Peripheral Vascular Inc
Published: 2008-12-23
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2008-12-23 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBL06040 on 2008-12-23. The reason FDA records is "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"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1454-2009
Status: Terminated
Initiated: 2008-12-23
Posted: 2009-06-17
Terminated: 2012-04-02
Recalling firm: Bard Peripheral Vascular Inc
Product: Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBL06040.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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".
Root cause tag: manufacturing process
FDA root cause: 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 [email protected].
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.
Product codes and lots: Lot Number: ANSG2329.

Product code FGE

K063532Class IIBard E Luminexx Biliary StentBard Peripheral Vascular, Inc. / cleared 2008-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)