FDA-Device2025-03-26Class II
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Hazard
Potential breach in pouch packaging which could lead to loss of sterility.
Sold states
US Nationwide distribution.
Affected count
220 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2025Don't want to check this manually?
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