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[Recalled] Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670 — Product manufactured between September 29, 2017 and September 12, 2019 have bee… | FDA 2019-10-21

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductBoston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670
Brand / manufacturerBoston Scientific Corporation
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0554-2020
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date21 October 2019
EAN / barcode21376782

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Boston Scientific Corporation

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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