Sanarus Medical Inc
Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)
| Date | Jul 15, 2003 (initiated Jun 16, 2003) |
| Status | Terminated |
| Reason | Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure. |
| Root cause | Other |
| Action | A recall notification letter was sent via Federal Express to all affected customers on 06/16/2003. |
| Quantity | 41 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022314 | SANARUS VISICA TREATMENT SYSTEM Sanarus Medical, Inc., Oct 15, 2002 |