FDAFDA · Food and drugs·Recall number Z-1428-2013
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
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 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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