FDAFDA · Food and drugs·Recall number Z-0557-2020
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
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: 21483842 21512596 21724129 21806787 21973221 22307744 22460195 23073639 23492663 24271829
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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