Bard Peripheral Vascular Inc Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120.
Brand
Bard Peripheral Vascular Inc
Lot Codes / Batch Numbers
Lot Number: ANSJ0893.
Products Sold
Lot Number: ANSJ0893.
Bard Peripheral Vascular Inc is recalling Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120. due to 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 indica. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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".
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026