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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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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 Number Z-0614-2011
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
Consumer Instructions Contact the recalling firm for information
Reason for
Recall		 Sterility may be compromised by a loss of package integrity.
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.
 
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