Device product

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

Z-0554-2020

October 21, 2019

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 84150
Status: Terminated
Classification: Class II
Quantity: 651 units
Official record key: device-enforcement:Z-0554-2020

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

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