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U.S. Department of Health and Human Services

Class 2 Device Recall Visica

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  Class 2 Device Recall Visica see related information
Date Initiated by Firm June 16, 2003
Date Posted July 15, 2003
Recall Status1 Terminated 3 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/
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 2
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.