FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120.
- Recall number
- Z-1453-2009
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120.
- Status
- Terminated
- Initiated
- 2008-12-23
- Posted
- 2009-06-17
- Terminated
- 2012-04-02
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Lot Number: ANSJ0893.
- 510(k) numbers
- ["K063532"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28