FDA Enforcement
Class II
Terminated
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
Recall: Z-0557-2020
·
Reported December 4, 2019
Enforcement
- Recall Number
- Z-0557-2020
- 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 12cm UPN: M00536700
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: 21483842 21512596 21724129 21806787 21973221 22307744 22460195 23073639 23492663 24271829
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
271 units