FDA Enforcement
Class II
Ongoing
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Recall: Z-1317-2024
·
Reported March 27, 2024
Enforcement
- Recall Number
- Z-1317-2024
- Event ID
- 94167
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 27, 2024
- Initiation Date
- February 16, 2024
- Classification Date
- March 19, 2024
- Address
- 4600 Nathan Ln N, Plymouth, MN, 55442-2890, United States
Description
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Reason
There is a potential for sterile package breach.
Code Info
a) AB9U14080090, UDI/DI 00643169796294, Batch Number B456626; b) AB9U18100090, UDI/DI 00643169796409, Batch Number B456811; c) AB9G14100090, IUDI/DI 00763000547325, Batch Number B460542
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, United Kingdom.
Quantity
65 units