FDA Recall
Terminated
Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)
Recall: Z-1008-03
·
Initiated June 16, 2003
Recall
- Recall Number
- Z-1008-03
- Event Number
- 26582
- Firm
- Sanarus Medical Inc
- FEI Number
- 3003515897
- Status
- Terminated
- Root Cause
- Other
- Initiated
- June 16, 2003
- Posted
- July 15, 2003
- Terminated
- August 22, 2003
- Address
- 5880 West Las Positas, Suite 52, Pleasanton, CA, 95488
Description
Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)
Reason
Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.
Action
A recall notification letter was sent via Federal Express to all affected customers on 06/16/2003.
Distribution
Product was released for distribution to 12 consignees across the United States, including US states: GA, WI, TX and NY. A total of 41 units from the lot had been shipped to these consignees. The recall was extended to the user level who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
Quantity
41