| Class 2 Device Recall Abre Venous Selfexpanding Stent System |  |
Date Initiated by Firm | February 16, 2024 |
Date Posted | March 19, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1317-2024 |
Recall Event ID |
94167 |
Product Classification |
Stent, iliac vein - Product Code QAN
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Product | Abre Venous Self-expanding Stent System, Product Numbers:
a) AB9U14080090;
b) AB9U18100090;
c) AB9G14100090 |
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 |
Recalling Firm/ Manufacturer |
Medtronic Inc. 4600 Nathan Ln N Plymouth MN 55442-2890
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For Additional Information Contact | PVH Customer Service 763-716-6700 |
Manufacturer Reason for Recall | There is a potential for sterile package breach. |
FDA Determined Cause 2 | Process control |
Action | 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. |
Quantity in Commerce | 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.
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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