Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0558-2020 — Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710

U.S. FDA — Device Enforcement · United States · 2019-10-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0558-2020
Date of alert
2019-10-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
21750674
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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