Single Site Curved Needed Driver Intuitive Surgical recall
Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used…
Why was Single Site Curved Needed Driver 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 428088-12 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130521 S10130405 S10130401 S10130405 S10130405 S10130521 S10130405 S10130405 S10130406 S10130406 S10130411 S10130411 S10130613 S10130405 S10130327 S10130327 S10130319 S10130319 S10130626 S10130703 S10130405 S10130319 S10130521 S10130613 S10130502 S10130405 S10130401 S10130406 S10130521 S10130613 S10130502 S10130406 S10130411 S10130405 S10130327 S10130412 S10130613 S10130314 S10130411 S10130327 S10130327 S10130411 S10130406 S10130613 S10130626 S10130412 S10130521 S10130405 S10130405 S10130314 S10130401 S10130411 S10130626 S10130703 S10130703 S10130703 S10130626 S10130613 S10130502 S10130401 S10130412 S10130406 Batch/Lot # S10130412 S10130405 S10130412 S10130314 S10130319 S10130502 S10130613 S10130405 S10130314 S10130405 S10130405 S10130613 S10130709 S10130703 S10130314 S10130319 S10130319 S10130314 S10130412 S10130521 S10130626 S10130411 S10130405 S10130521 S10130405 S10130319 S10130319 S10130319 S10130405 S10130405 S10130405 S10130314 S10130314 S10130314 S10130314 S10130319 S10130319 S10130319 S10130319 S10130314 S10130314 S10130314 S10130405 S10130327 S10130327 S10130405 S10130405 S10130412 S10130405 S10130327 S10130406 S10130406 S10130406 S10130613 S10130502 S10130613 S10130502 S10130521 S10130502 S10130613 S10130411 S10130502 Batch/Lot # S10130412 S10130521 S10130521 S10130521 S10130521 S10130613 S10130521 S10130405 S10130401 S10130405 S10130405 S10130613 S10130613 S10130703 S10130703 S10130319 S10130319 S10130626 S10130703 S10130405 S10130405 S10130405 S10130405 S10130521 S10130521 S10130405 S10130327 S10130406 S10130412 S10130412 S10130411 S10130401 S10130405 S10130521 S10130502 S10130406 S10130613 S10130411 S10130613 S10130613 S10130405 S10130401 S10130327 S10130405 S10130406 S10130405 S10130405 S10130405 S10130319 S10130319 S10130406 S10130406 S10130703 S10130613 S10130502 S10130412 S10130412 S10130406 S10130406 S10130521 S10130626 S10130405 S10130401 S10130412 S10130405 S10130405 S10130613 S10130502
- Product
- Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 504 devices 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)