Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670

FDA Recall Z-0554-2020 · Posted 2019-11-25

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFGE
Date Initiated2019-10-21
Date Terminated2023-12-20
Product Quantity651 units

Reason for Recall

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

Firm Action

Boston Scientific issued Notifications to consignees via Federal Express Priority mail on October 21, 2019. The notification instructs the account to check their inventory remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.

Root Cause

Incorrect or no expiration date

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑