FDA Enforcement
Class II
Terminated
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690
Recall: Z-0556-2020
·
Reported December 4, 2019
Enforcement
- Recall Number
- Z-0556-2020
- Event ID
- 84150
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 4, 2019
- Initiation Date
- October 21, 2019
- Classification Date
- November 25, 2019
- Termination Date
- December 20, 2023
- Address
- 300 Boston Scientific Way, Marlborough, MA, 01752-1291, United States
Description
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690
Reason
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
Code Info
Lot Numbers: 21568465 21724128 22072356 22250324 22480145 23902872
Distribution
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
Quantity
139 units