VersaOne Reusable Positioning Cannula 12mm Standard recall: Foreign Material
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Why was VersaOne Reusable Positioning Cannula 12mm Standard recalled?
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
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?
UDI-DI: 10884521784062; Serial Numbers: C21RXG0005
- Product
- VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
- Recalling firm
- Covidien LP
- Quantity
- 1 units
- Distribution
- Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
- Recall date
- May 3, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)