Date Initiated by Firm |
August 26, 2015 |
Date Posted |
September 18, 2015 |
Recall Status1 |
Terminated 3 on February 10, 2017 |
Recall Number |
Z-2780-2015 |
Recall Event ID |
72046 |
Product Classification |
Probe Blood-Flow extra vascular - Product Code DPT
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Product |
ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch.
The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery.
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Code Information |
Model: KP1 - Lot No: 59964698, 59967596, 59984375, 60016312, 60045801, 60045802, 60059982, 60066591, 60089865 Model VPP Lot No: 60022521, 60022522, 60064112 |
Recalling Firm/ Manufacturer |
Edwards Lifesciences, LLC 12050 Lone Peak Pkwy Draper UT 84020-9414
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For Additional Information Contact |
Sherri Robbins 801-553-7531
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Manufacturer Reason for Recall |
The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the integrity of the suture knot.
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FDA Determined Cause 2 |
Process control |
Action |
Edwards sent an Urgent-Product Recall - Action Required letter dated August 26, 2015, to all affected customers. Letters were sent via Fed-Ex.
Please check your inventory for the affected Lot Numbers listed above and return the enclosed confirmation form. If your inventory includes affected product, please contact Edwards Lifesciences to obtain an RGA number and return the affected product.
We apologize for the inconvenience caused by this action and appreciate your attention to this matter. If you have questions that have not been answered by this letter, please call Edwards Customer Service at (800) 424-3278 from 6:00AM 4:30PM Pacific Time. |
Quantity in Commerce |
759 units |
Distribution |
Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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