Bard E LUMINEXX Biliary Stent, Size: 14mm x 30mm, Product Number: ZBM14030.
FDA device recall Z-1466-2009 · posted 2009-06-17 · Terminated
Recall details
- Recalling firm
- Bard Peripheral Vascular Inc
- 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".
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 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.
- Date initiated
- 2008-12-23
- Date posted
- 2009-06-17
- Date terminated
- 2012-04-02
- Location
- Tempe, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARD E LUMINEXX BILIARY STENT (K063532) | Bard Peripheral Vascular, Inc. | 2008-05-30 |