FDAClass IISeptember 19, 2012

Tip Cover for 8mm Monopolar Curved Scissors recall: Sterility Concern

Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to…

Why was Tip Cover for 8mm Monopolar Curved Scissors recalled?

There is potential for the sterility of the product to be compromised.

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 No. 400180-12 Lot No: M10120601 M10120430 M10120329 M10120312 M10111214 M10120516 M10120426 M10120321 M10120208 M10111208 M10120510 M10120419 M10120317 M10120207 M10111201 M10120507 M10120413 M10120315 M10120130 M10111028

Product
Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to…
Recalling firm
Intuitive Surgical, Inc.
Quantity
11,121 Boxes
Distribution
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Canada, and Lebanon
Recall date
September 19, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls