Tip Cover Accessory recall: Labeling Error
Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved…
Why was Tip Cover Accessory recalled?
Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
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: 400180-10 and prior versions 400180-01, 400180-02, 400180-03, 400180-04, 400180-05, 400180-05, 400180-06. 400180-07, 400180-08 and 400180-09.
- Product
- Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 50,000 boxes of 10 tip covers
- Distribution
- Worldwide distribution - USA Nationwide and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
- Recall date
- June 5, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)