Z-2958-2020 Class II Terminated
FDA device recall Z-2958-2020 was initiated by Boston Scientific Corporation on August 7, 2020 and is designated Class II. Reason for recall: Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device The recall status is terminated (terminated December 23, 2020). Affected quantity: 40 units.
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