FDAFDA · Food and drugs·Recall number Z-0554-2020
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670
Published December 4, 2019 · Recall initiated: October 21, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- 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
- Lot
- Lot Numbers: 21376782 21636753 21724127 21833853 22007181 22136472 22195529 22212529 22522255 22613956 22858807 23073638 23321211 23408729 23875252 24167479 24229866 24411528
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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