Vacuum Source Tubing Set for the EndoWrist Stabilizer recall: Sterility Concern
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist…
Why was Vacuum Source Tubing Set for the EndoWrist Stabilizer recalled?
There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.
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?
all PN 410187-05
- Product
- Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 706 units
- Distribution
- US and Belgium, Brazil, Canada, China, Finland, France, Greece, India, Italy, Japan, Qatar, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom
- Recall date
- March 11, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)