Z-0550-2020 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
542 units

Product Description

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630

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: 21483840 21512594 21724125 21833851 22007180 22195528 22212528 22647190 22828072 23000367 23257632 23578453 23615959 23796006 24167478 24229865 24396823