Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Reported: March 27, 2024 Initiated: February 16, 2024 #Z-1317-2024
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.
Details
- Recalling Firm
- Medtronic Inc.
- Units Affected
- 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.
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090. Recalled by Medtronic Inc.. Units affected: 65 units.
Why was this product recalled? ▼
There is a potential for sterile package breach.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2024. Severity: Moderate. Recall number: Z-1317-2024.
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