FDAClass IIJune 5, 2013

Cannula 8MM Regular. Provides the means of introduction recall: Labeling Error

Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.

Why was Cannula 8MM Regular. Provides the means of introduction 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 number 420002-07

Product
Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
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)
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