Abre Venous Self-expanding Stent System recall
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Why was Abre Venous Self-expanding Stent System recalled?
There is a potential for sterile package breach.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) AB9U14080090, UDI/DI 00643169796294, Batch Number B456626; b) AB9U18100090, UDI/DI 00643169796409, Batch Number B456811; c) AB9G14100090, IUDI/DI 00763000547325, Batch Number B460542
- Product
- Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
- Recalling firm
- Medtronic Inc.
- Quantity
- 65 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, United Kingdom.
- Recall date
- March 27, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)