daVinci Harmonic ACE Curved Shears recall: Sterility Concern
daVinci Harmonic ACE Curved Shears
Why was daVinci Harmonic ACE Curved Shears recalled?
During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 Lots
- Product
- daVinci Harmonic ACE Curved Shears
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 43755 inserts
- Distribution
- US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Korea, Spain, Taiwan, Turkey, United Kingdom
- Recall date
- February 27, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)