Device product

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650

Z-0552-2020

October 21, 2019

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 84150
Status: Terminated
Classification: Class II
Quantity: 940 units
Official record key: device-enforcement:Z-0552-2020

Official wording

Reason: 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

Code information: Lot Numbers: 21187998 21285271 21337147 21483841 21512595 21662812 21724126 21833852 21922988 22036149 22136471 22307745 22359735 22613955 22700891 23035017 23295961 23492660 23541961 24006978 24271828 24383293 24411526

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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