Recall Z-1465-2009
Bard Peripheral Vascular Inc · initiated December 23, 2008
Product
Bard E LUMINEXX Biliary Stent, Size: 12mm x 80mm Product Number: ZBM12080.
Codes / lots: Lot Numbers: ANSH0792 and ANSI0311.
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".
FDA-determined cause: Employee error
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.
Details
- Recall number
- Z-1465-2009
- Initiated
- December 23, 2008
- Posted by FDA
- June 17, 2009
- Terminated
- April 2, 2012
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- 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.
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1453-2009 | Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1454-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBL06040.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1455-2009 | Bard E LUMINEXX, Biliary Stent Size: 6mm x 80mm, Product Number: ZBL06080.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1456-2009 | Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBL12040.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1457-2009 | Bard E LUMINEXX Biliary Stent, Size: 14mm x 60mm, Product Number: ZBL14060.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1458-2009 | Bard E LUMINEXX Biliary Stent,Size: 6mm x 20mm, Product Number: ZBM06020.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1459-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 30mm, Product Number: ZBM06030.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1460-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBM06040.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1461-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 60mm, Product Number: ZBM06060.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1462-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 80mm, Product Number: ZBM06080.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1463-2009 | Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBM12040.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1464-2009 | Bard E LUMINEXX Biliary Stent, Size: 12mm x 60mm, Product Number: ZBM12060.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1466-2009 | Bard E LUMINEXX Biliary Stent, Size: 14mm x 30mm, Product Number: ZBM14030.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1467-2009 | Bard E LUMINEXX Biliary Stent, Size: 14mm x 40mm, Product Number: ZBM14040.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1468-2009 | Bard E LUMINEXX Biliary Stent, Size 14mm x 60mm, Product Number: ZBM14060.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1469-2009 | Bard E LUMINEXX Biliary Stent, Size: 14mm x 80mm, Product Number: ZBM14080.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |