FDAClass IIDecember 4, 2019

Boston Advanix Pancreatic Stent recall

Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620

Why was Boston 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: 21776487 22136470 22896244 23902871

Product
Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620
Recalling firm
Boston Scientific Corporation
Quantity
66 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