FDA-Device2023-05-03Class II
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
Covidien LP
Hazard
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.
Sold states
Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
Affected count
51 units
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1464-2023Don't want to check this manually?
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