FDAFDA · Food and drugs·Recall number Z-0550-2020
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630
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: 21483840 21512594 21724125 21833851 22007180 22195528 22212528 22647190 22828072 23000367 23257632 23578453 23615959 23796006 24167478 24229865 24396823
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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