Z-2958-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2020
- Initiation Date
- August 7, 2020
- Termination Date
- December 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 units
Product Description
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.
Reason for Recall
Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
Distribution Pattern
US Nationwide distribution.
Code Information
Lot code:25607019 Exp. Date: June 17th , 2022 GIN:08714729953180