Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
FDA Recall #Z-1428-2013 — Class II — September 19, 2011
Product Description
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
Reason for Recall
Clarification of existing labeling information and operating procedures.
Recalling Firm
Intuitive Surgical, Inc. — Sunnyvale, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated