||December 13, 2010
||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
||Affected Lot Number Range: 8030373 to 8112071
|CTS, Inc. dba Guidant Cardiac Surgery
170 Baytech Dr
San Jose, California 95134-2302
|Sterility may be compromised by a loss of package integrity.
||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: Nationwide and Internationally.