Z-0548-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2019
- Initiation Date
- October 21, 2019
- Termination Date
- December 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109 units
Product Description
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610
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
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
Code Information
Lot Numbers: 21312746 21776485 22737577 23257631 24271827