Device product

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710

Z-0558-2020

October 21, 2019

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 84150
Status: Terminated
Classification: Class II
Quantity: 66 units
Official record key: device-enforcement:Z-0558-2020

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: 21750674 22036150 22647191 23902873

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