Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)
FDA device recall Z-1008-03 · posted 2003-07-15 · Terminated
Recall details
- Recalling firm
- Sanarus Medical Inc
- Reason for recall
- Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.
- Action taken
- A recall notification letter was sent via Federal Express to all affected customers on 06/16/2003.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 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 reca
- Date initiated
- 2003-06-16
- Date posted
- 2003-07-15
- Date terminated
- 2003-08-22
- Location
- Pleasanton, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SANARUS VISICA TREATMENT SYSTEM (K022314) | Sanarus Medical, Inc. | 2002-10-15 |