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U.S. Department of Health and Human Services

Class 2 Device Recall Electrosurgical Cutting and Coagulation Device

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  Class 2 Device Recall Electrosurgical Cutting and Coagulation Device see related information
Date Initiated by Firm December 12, 2013
Date Posted February 21, 2014
Recall Status1 Terminated 3 on July 28, 2015
Recall Number Z-1069-2014
Recall Event ID 67193
510(K)Number K092789  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only***

Product Usage:
The VirtuoSaph  Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
Code Information Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd
Elkton MD 21921-5315
For Additional Information Contact Mary Swift
734-741-6056
Manufacturer Reason
for Recall		 Sterility of medical devices intended for use in surgical procedures may be compromised.
FDA Determined
Cause 2		 Process control
Action Terumo CVS notified afected end users by phone on December 12, 2013 and advised that they had become aware that the sterile packaging barrier was breached in specific lots of VirtuoSaph¿ Plus Endoscopic Vessel Harvesting Systems. Customers were requested to return all unused affected product and verify that all users at their institution have been made aware of the risks associated with using the affected devices. For questions call 734-663-4145.
Quantity in Commerce 26 units
Distribution USA Nationwide Distribution in the state of LA, NJ, and NY.
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 = GCJ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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