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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
Recall Number Z-1428-2013
Classification Class II
Code Info 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.
Product Distributed Qty NA
Reason For Recall Clarification of existing labeling information and operating procedures.

Event Detail

Event Id 65083
Product Type Devices
Status Terminated
Recalling Firm Intuitive Surgical, Inc.
City Sunnyvale
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-09-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.