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U.S. Department of Health and Human Services

Class 2 Device Recall Heartstring II Proximal Seal/VASOVIEW 6 Endoscopic Vessel Harvesting System

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 Class 2 Recall
Heartstring II Proximal Seal/VASOVIEW 6 Endoscopic Vessel Harvesting System
see related information
Date Posted December 13, 2010
Recall Status1 Terminated on January 19, 2011
Recall Number Z-0614-2011
Recall Event ID 51242
Premarket Notification
510(K) Number
K030512 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model Number: VH-2000, Product is manufactured and distributed by Maquet Corporation San Jose, CA
Code Information Affected Lot Number Range: 8030373 to 8112071
Recalling Firm/
Manufacturer
CTS, Inc. dba Guidant Cardiac Surgery
170 Baytech Dr
San Jose, California 95134-2302
Manufacturer Reason
for Recall
Sterility may be compromised by a loss of package integrity.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Maquet issued an Urgent Device Removal letter dated February 5, 2009 to customers, explaining the reason for the recall and requesting the product be returned for replacement. Customers were instructed to examine their inventory and discontinue distribution and use of the affected devices. Customers also were requested to complete and return a Field Action Response Form. Maquet can be contacted at 888-880-2874 concerning this recall.
Distribution Distribution: Nationwide and Internationally.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = GUIDANT CORP.
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