Class 2 Device Recall Visica

• Date Initiated by Firm: June 16, 2003
• Date Posted: July 15, 2003
• Recall Status: Terminated on August 22, 2003
• Recall Number: Z-1008-03
• Recall Event ID: 26582
• 510(K)Number: K022314
• Product: Sanarus Visica¿ Treatment System (disposable), Model/Product Code: VP-0500 (single)
• Code Information: Lot # C030404
• Recalling Firm/ Manufacturer: Sanarus Medical Inc; 5880 West Las Positas Suite 52; Pleasanton CA 95488
• For Additional Information Contact: Trena Depel; 925-460-6080 Ext. 6715
• Manufacturer Reason for Recall: Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.
• FDA Determined Cause: Other
• Action: A recall notification letter was sent via Federal Express to all affected customers on 06/16/2003.
• Quantity in Commerce: 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 U.S. Government facilities or foreign or Canadian distribution.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = and Original Applicant = SANARUS MEDICAL, INC.