Z-0553-2020 Class II Terminated
FDA device recall Z-0553-2020 was initiated by Boston Scientific Corporation on October 21, 2019 and is designated Class II. 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 The recall status is terminated (terminated December 20, 2023). Affected quantity: 97 units.
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
- 97 units
Product Description
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660
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: 21312747 21865108 22275742 24411527