Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965
This recall has been terminated (originally issued July 20, 2004).
- Company
- Boston Scientific Corporation
- Recall Initiated
- January 28, 2004
- Posted
- July 20, 2004
- Terminated
- June 28, 2006
- Recall Number
- Z-0563-04
- Quantity
- 12 units
- Firm Location
- Natick, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect label states stent covered with 'Permalume Covering', product is uncovered
Distribution
CA, GA, , MD, NY, OR, ND, PA Netherlands
Lot / Code Info
Lot Number: 6023979
Root Cause
Other
Action Taken
Boston Scientific notified domestic and international accounts by letter on 1/28/04. Accounts are requested to return product.