FDA-Device2017-12-13Class II
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent airway management.
Intersurgical Inc
Hazard
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Sold states
Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico
Affected count
144 cases / 20 units
Manufactured in
6757 Kinne St., N/A, E. Syracuse, NY, United States
Products
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent airway management.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0208-2018Don't want to check this manually?
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