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U.S. Department of Health and Human Services

Class 2 Device Recall Flush Port

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 Class 2 Device Recall Flush Port see related information
Date Posted May 29, 2013
Recall Status1 Terminated on May 30, 2013
Recall Number Z-1428-2013
Recall Event ID 65083
510(K)Number K050369 
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product Flush Port (used in almost all da Vinci instruments)

Assists in cleaning the instrument.
Code Information Model numbers:
340066-07 - straight;
340234-02 - extended taper;
340241-03 - 5mm;
340584-01 - Gemini 8mm straight;
340586-02 - Gemini 5mm;
340725-01 - Vespa straight;
340800-01 - Gemini ext taper;
340971-01 - IS1200 Grasping
340972-01 IS2000 Grasping.
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Richard Reeves
Manufacturer Reason
for Recall
Clarification of existing labeling information and operating procedures.
FDA Determined
Cause 2
Labeling False and Misleading
Action Intuitive Surgical sent an "IMPORTANT PRODUCT NOTIFICATION" letter dated October 17, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 1-800-876-1310 for questions regarding this notice.
Quantity in Commerce NA
Distribution Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.