FDA Recall
Terminated
Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557
Recall: Z-1019-03
·
Initiated June 26, 2003
Recall
- Recall Number
- Z-1019-03
- Event Number
- 26644
- Firm
- Boston Scientific Corporation
- FEI Number
- 3001451463
- Status
- Terminated
- Root Cause
- Other
- Initiated
- June 26, 2003
- Posted
- July 15, 2003
- Terminated
- April 21, 2005
- Address
- 1 Boston Scientific Place, Natick, MA, 01760
Description
Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557
Reason
Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm
Action
Boston Scientific notified domestic and internationnal accounts by letter on 6/26/03. Users are advised to check inventory and return product. A Reply Verification form was required to returned by fax to determine accountability.
Distribution
CO, FL, IA, IL, NY, VT,TX Foreign: Singapore, Korea
Quantity
23 units