Device product
WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
Z-2958-2020
Product summary
- Event
- Event 86226
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-2958-2020
Official wording
Reason: Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
Code information: Lot code:25607019 Exp. Date: June 17th , 2022 GIN:08714729953180
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
Mislabeled