Recall Z-1317-2024
Medtronic Inc. · initiated February 16, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Codes / lots: a) AB9U14080090, UDI/DI 00643169796294, Batch Number B456626; b) AB9U18100090, UDI/DI 00643169796409, Batch Number B456811; c) AB9G14100090, IUDI/DI 00763000547325, Batch Number B460542
Reason for recall
There is a potential for sterile package breach.
FDA-determined cause: Process control
Action taken
Medtronic issued and URGENT: MEDICAL DEVICE RECALL notice to it consignees on 02/16/2024 via FedEx. The notice explained the issue and requested the consignee immediately remove, and quarantine all impacted devices pending a follow-up communication providing additional information pertaining to product retrieval for this issue within 2-3 weeks.
Details
- Recall number
- Z-1317-2024
- Initiated
- February 16, 2024
- Posted by FDA
- March 19, 2024
- Product code
- QAN – Stent, Iliac Vein
- 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.
- Recalling firm
- Medtronic Inc., Plymouth, MN