Device product
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Z-1317-2024
Product summary
- Firm
- Medtronic Inc.
- Event
- Event 94167
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 65 units
- Official record key
device-enforcement:Z-1317-2024
Official wording
Reason: There is a potential for sterile package breach.
Code information: 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 pattern: Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, United Kingdom.
Derived failure modes
-
Sterility assurance
sterile package breach