Z-1317-2024 Class II Ongoing
FDA device recall Z-1317-2024 was initiated by Medtronic Inc. on Feb 16, 2024 and is designated Class II. Reason for recall: There is a potential for sterile package breach. The recall status is ongoing. Affected quantity: 65 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 27, 2024
- Initiation Date
- Feb 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 units
Product Description
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Reason for Recall
There is a potential for sterile package breach.
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1317-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026