Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or acce...
FDA Recall #Z-1427-2013 — Class II — September 19, 2011
Product Description
Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
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 number 420002-07
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated