Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557
This recall has been terminated (originally issued July 15, 2003).
- Company
- Boston Scientific Corporation
- Recall Initiated
- June 26, 2003
- Posted
- July 15, 2003
- Terminated
- April 21, 2005
- Recall Number
- Z-1019-03
- Quantity
- 23 units
- Firm Location
- Natick, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm
Distribution
CO, FL, IA, IL, NY, VT,TX Foreign: Singapore, Korea
Lot / Code Info
Lot Number: 5404484
Root Cause
Other
Action Taken
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.