FDA-Device2025-08-13Class II
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Intersurgical Inc
Hazard
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Sold states
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Affected count
2,800 pieces
Manufactured in
5010 Campuswood Dr Ste 102, N/A, East Syracuse, NY, United States
Products
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2275-2025Don't want to check this manually?
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