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
This recall has been terminated (originally issued December 13, 2010).
- Recall Initiated
- February 5, 2009
- Posted
- December 13, 2010
- Terminated
- January 19, 2011
- Recall Number
- Z-0614-2011
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility may be compromised by a loss of package integrity.
Distribution
Distribution: Nationwide and Internationally.
Lot / Code Info
Affected Lot Number Range: 8030373 to 8112071
Root Cause
Packaging
Action Taken
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.