FDA Recall
Terminated
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
Recall: Z-0614-2011
·
Initiated February 5, 2009
Recall
- Recall Number
- Z-0614-2011
- Event Number
- 51242
- Firm
- CTS, Inc. dba Guidant Cardiac Surgery
- FEI Number
- 3000719698
- Product Code
- GCJ
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- February 5, 2009
- Posted
- December 13, 2010
- Terminated
- January 19, 2011
- Address
- 170 Baytech Dr, San Jose, CA, 95134-2302
Description
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
Reason
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.