Single Site Bipolar Maryland Forceps Intuitive Surgical recall
Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories…
Why was Single Site Bipolar Maryland Forceps Intuitive Surgical recalled?
A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.
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 428080-04 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130510 S10130325 S10130314 S10130314 S10130415 S10130426 S10130329 S10130228 S10130418 S10130304 S10130418 S10130325 S10130325 S10130408 S10130408 S10130510 S10130415 S10130304 S10130314 S10130415 S10130418 S10130228 S10130329 S10130329 S10130415 S10130426 S10130426 S10130426 S10130408 S10130325 S10130228 S10130325 S10130426 S10130426 S10130418 S10130325 S10130510 S10130408 S10130415 S10130408 S10130228 S10130304 S10130418 S10130415 S10130426 S10130314 S10130426 S10130418 S10130228 S10130228 S10130304 S10130415 S10130415 S10130418 S10130408 S10130329 S10130314 S10130228 S10130228 S10130314 S10130325 S10130415 S10130426 Batch/Lot # S10130426 S10130418 S10130408 S10130325 S10130415 S10130415 S10130415 S10130418 S10130325 S10130325 S10130329 S10130325 S10130314 S10130329 S10130426 S10130314 S10130408 S10130329 S10130426 S10130426 S10130325 S10130415 S10130426 S10130426 S10130325 S10130325 S10130325 S10130329 S10130329 S10130408 S10130415 S10130408 S10130408 S10130415 S10130415 S10130418 S10130426 S10130415 S10130325 S10130408 S10130418
- Product
- Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 286 boxes ( 6 instruments per box) for a total of 2,220 affected clinical product
- Distribution
- Worldwide distribution: US (nationwide) and countries of:Australia, Belgium, France, Italy and United Kingdom. .
- Recall date
- November 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)