Z-0554-2020 Class II Terminated

Recalled by Boston Scientific Corporation — Marlborough, MA

Recall Details

Product Type
Devices
Report Date
December 4, 2019
Initiation Date
October 21, 2019
Termination Date
December 20, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
651 units

Product Description

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670

Reason for Recall

Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life

Distribution Pattern

Nationwide Foreign: Austria Australia Belgium Bulgaria Croatia Czech Rep Denmark Finland France Germany Great Britain Italy Japan Pakistan Poland Russian Fed. Slovakia South Africa Spain Sweden Switzerland Thailand Turkey

Code Information

Lot Numbers: 21376782 21636753 21724127 21833853 22007181 22136472 22195529 22212529 22522255 22613956 22858807 23073638 23321211 23408729 23875252 24167479 24229866 24411528