FDAFDA · Food and drugs·Recall number Z-1427-2013
Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
Published June 5, 2013 · Recall initiated: September 19, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Clarification of existing labeling information and operating procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- 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.
- Lot
- Model number 420002-07
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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