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Class 2 Device Recall AtriCure Reusable Clip Applier |
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Date Initiated by Firm |
January 23, 2014 |
Date Posted |
March 14, 2014 |
Recall Status1 |
Terminated 3 on May 13, 2014 |
Recall Number |
Z-1209-2014 |
Recall Event ID |
67572 |
Product Classification |
Applier, hemostatic clip - Product Code HBT
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Product |
Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069.
The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage. |
Code Information |
Lot Number MFR-0424-1 |
Recalling Firm/ Manufacturer |
Atricure Inc 6217 Centre Park Drive West Chester OH 45069
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For Additional Information Contact |
Mr. Anupam K. Bedi 513-755-4563
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Manufacturer Reason for Recall |
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
On 1/24/2014 the firm sent Urgent Recall Notification letters to their customers. |
Quantity in Commerce |
46 units |
Distribution |
Nationwide Distribution-including the states of AL, CA, CO, CT, DE, FL, KY, MD, MI, MN, MO, NC, NY, OH, OR, PA, TN, UT, VA & WA. |
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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