Device product

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700

Z-0557-2020

October 21, 2019

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 84150
Status: Terminated
Classification: Class II
Quantity: 271 units
Official record key: device-enforcement:Z-0557-2020

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: 21483842 21512596 21724129 21806787 21973221 22307744 22460195 23073639 23492663 24271829

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