Recall Z-1464-2009 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Bard Peripheral Vascular Inc
Bard E LUMINEXX Biliary Stent, Size: 12mm x 60mm, Product Number: ZBM12060.
| Date | Jun 17, 2009 (initiated Dec 23, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063532 | BARD E LUMINEXX BILIARY STENT Bard Peripheral Vascular, Inc., May 30, 2008 |