Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)
This recall has been terminated (originally issued July 15, 2003).
- Company
- Sanarus Medical Inc
- Recall Initiated
- June 16, 2003
- Posted
- July 15, 2003
- Terminated
- August 22, 2003
- Recall Number
- Z-1008-03
- Quantity
- 41
- Firm Location
- Pleasanton, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.
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.
Lot / Code Info
Lot # C030404
Root Cause
Other
Action Taken
A recall notification letter was sent via Federal Express to all affected customers on 06/16/2003.