[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
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670 |
|---|---|
| Brand / manufacturer | Boston Scientific Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0554-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 October 2019 |
| EAN / barcode | 21376782 |
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.