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U.S. Department of Health and Human Services

Class 2 Device Recall CLEARGLIDE PRECISION BIPOLAR DEVICE

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  Class 2 Device Recall CLEARGLIDE PRECISION BIPOLAR DEVICE see related information
Date Initiated by Firm November 25, 2009
Date Posted January 14, 2010
Recall Status1 Terminated 3 on October 04, 2010
Recall Number Z-0624-2010
Recall Event ID 54000
510(K)Number K003587  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Sorin / Clearglide EVH Small, REF KTV15, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.

The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
Code Information Lot numbers: 0910300035, 0911100013, 0911700032, 0912400207, 0913100044, 0921500031, 0923700087, 0924300023, 0925100112, 0925100116, 092700175, 0929400008, 0929900092, 0930700014.
Recalling Firm/
Manufacturer		 Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004
For Additional Information Contact
303-467-6306
Manufacturer Reason
for Recall		 Vessel clamping device may break during use.
FDA Determined
Cause 2		 Component change control
Action Consignees were notified by "Urgent Field Safety Notice" dated November 24, 2009 with instructions to examine the device before, during and after use. Customers were instructed to not use the device, if it is damaged. Customers were also instructed to contact the Sorin Group Customer Service at 1-800-650-2623 to arrange shipment of replacement product and requested to complete and return the response form. Direct questions to the Sorin Group Customer Service at 1-800-650-2623.
Quantity in Commerce 2796 units
Distribution Worldwide Distribution -- United States, Australia, Canada and Italy.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = ETHICON, INC.
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