Flush Port recall: Labeling Error
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
Why was Flush Port recalled?
Clarification of existing labeling information and operating procedures.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
- Recalling firm
- Intuitive Surgical, Inc.
- 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.
- Recall date
- June 5, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)