VersaOne Reusable Positioning Cannula Recalled Due to Internal Metal Burrs
Covidien LP is recalling VersaOne Reusable Positioning Cannulas (Model RC12STS) due to manufacturing defects that may produce metal burrs on the inside of the device, potentially causing internal tissue damage during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for manufacturing defect that may cause internal tissue injury, but no illnesses or injuries have been reported. This is a risk-of-harm product where injury has not yet been reported, meeting the rubric criteria for 'High' severity.
Plain-English summary
Covidien LP is recalling VersaOne Reusable Positioning Cannula 12mm Standard (Model Number RC12STS) due to a manufacturing non-conformance that may result in metal shavings or burrs on the inside of the device at the weld joint between the Cannula and Body components.
The metal burrs present a potential risk of internal tissue damage or irritation if the device is used. The recalled product was distributed worldwide, including in the United States (North Carolina) and internationally in Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, and Sweden.
Patients or healthcare providers who have received this product should stop using it and contact Covidien LP for instructions on replacement or disposal. The product is identified by UDI-DI: 10884521784062 and Serial Number C21RXG0005.
The recalled product
- Product
- VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
- Manufacturer
- Covidien LP
- Category
- Medical Device
- Hazard
- metal-burr
- manufacturing-defect
- tissue-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 10884521784062
- Serial Numbers: C21RXG0005
Distribution
Distributed nationwide across the United States.
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