FDAClass IIDecember 4, 2019

Boston Scientific Advanix Pancreatic Stent recall

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

Why was Boston Scientific Advanix Pancreatic Stent recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650
Recalling firm
Boston Scientific Corporation
Quantity
940 units
Distribution
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
Recall date
December 4, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls