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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 Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
Recall Number Z-1427-2013
Classification Class II
Code Info Model number 420002-07
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.